My client has an exciting opportunity for a Principal Scientist to head up a small team developing the next generation protein therapeutics at their R&D facility in Cambridge, UK. As a Principal Scientist, you'll be involved in the design, production and testing of complex therapeutic proteins including multi-specifics and fusion proteins using state-of-the-art methodologies. As a small dynamic biotech company that works from concept to clinic, my client offers a great opportunity for you to make a real difference by progressing innovative proteins rapidly through the pipeline. As Principal Scientist, you will: Bring extensive protein engineering experience to the design of the next generation of protein therapeutics.Act as lead scientist and project leader on both pipeline and platform projects.Initiate and execute innovative research leading to the discovery of solutions to complex protein engineering challenges. Support projects across the company with novel modalities (including bispecific, multispecific and fusion proteins) to deliver efficacious and develop-able drugs.Collaborate both within the company and externally to ensure we're at the cutting edge of protein engineering for biologic drug discovery.Management of a small team of experienced scientists responsible for their development and the delivery of work through the team. To be considered for the role of Principal Scientist, you will have: Significant - 8 years plus - experience in protein engineering for drug discovery, demonstrated by delivery of therapeutic proteins to the clinic or high-impact publications.Experience of working with novel modalities (e.g. bispecifics, multi specifics, fusion proteins, immune cell engagers or ADCs) is a prerequisite to be successful in this role. You will be an acknowledged expert in advanced protein therapeutic discovery platforms such as in silico discovery, mammalian display or machine-learning data-driven approaches.Prior line management experience is highly desirable for this role.Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.Candidates must be eligible to live and work in the UK.For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.
My client has an exciting opportunity for a Principal Scientist to head up a small team developing the next generation protein therapeutics at their R&D facility in Cambridge, UK. As a Principal Scientist, you'll be involved in the design, production and testing of complex therapeutic proteins including multi-specifics and fusion proteins using state-of-the-art methodologies. As a small dynamic biotech company that works from concept to clinic, my client offers a great opportunity for you to make a real difference by progressing innovative proteins rapidly through the pipeline. As Principal Scientist, you will: Bring extensive protein engineering experience to the design of the next generation of protein therapeutics.Act as lead scientist and project leader on both pipeline and platform projects.Initiate and execute innovative research leading to the discovery of solutions to complex protein engineering challenges. Support projects across the company with novel modalities (including bispecific, multispecific and fusion proteins) to deliver efficacious and develop-able drugs.Collaborate both within the company and externally to ensure we're at the cutting edge of protein engineering for biologic drug discovery.Management of a small team of experienced scientists responsible for their development and the delivery of work through the team. To be considered for the role of Principal Scientist, you will have: Significant - 8 years plus - experience in protein engineering for drug discovery, demonstrated by delivery of therapeutic proteins to the clinic or high-impact publications.Experience of working with novel modalities (e.g. bispecifics, multi specifics, fusion proteins, immune cell engagers or ADCs) is a prerequisite to be successful in this role. You will be an acknowledged expert in advanced protein therapeutic discovery platforms such as in silico discovery, mammalian display or machine-learning data-driven approaches.Prior line management experience is highly desirable for this role.Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.Candidates must be eligible to live and work in the UK.For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.
Job Title: Data Management Analyst Location: Witney - Hybrid (2 days at home)Pay rate: £28,000 p,aContract: 12 Months (potential for permanent) Able to quickly learn and retain knowledge about new domains, technologies and approaches? Are you tech savvy and competent in excel? Is your work thorough and organised?Our client is a global healthcare organisation, who's main site in Witney is a hub of innovation and creativity. They are looking for a detail oriented person, with a positive attitude, to join the team as a Data Management Analyst. Key Responsibilities:Perform upload and verification of data from multiple sources.Track the entry and migration of clinical data and work with study team to identify erroneous, missing or incomplete data.Generate and track data queries to address data issues identified during verification.Document and verify transfer of clinical data.Perform qualification testing for in-house software.Perform data back-up when study laptops are returned.Report generation and preparing supporting documentationRequirements:A recent graduate or someone with a couple of years experience will be consideredMust be familiar with Microsoft packages - good knowledge of Excel. An analytical mindExperience working with multiple data sets would be an advantagePositive attitude and a willingness to learn Please apply with an up to date CV today and someone from the team will be in touch!Randstad Business Support is acting as an Employment Business in relation to this vacancy.
Job Title: Data Management Analyst Location: Witney - Hybrid (2 days at home)Pay rate: £28,000 p,aContract: 12 Months (potential for permanent) Able to quickly learn and retain knowledge about new domains, technologies and approaches? Are you tech savvy and competent in excel? Is your work thorough and organised?Our client is a global healthcare organisation, who's main site in Witney is a hub of innovation and creativity. They are looking for a detail oriented person, with a positive attitude, to join the team as a Data Management Analyst. Key Responsibilities:Perform upload and verification of data from multiple sources.Track the entry and migration of clinical data and work with study team to identify erroneous, missing or incomplete data.Generate and track data queries to address data issues identified during verification.Document and verify transfer of clinical data.Perform qualification testing for in-house software.Perform data back-up when study laptops are returned.Report generation and preparing supporting documentationRequirements:A recent graduate or someone with a couple of years experience will be consideredMust be familiar with Microsoft packages - good knowledge of Excel. An analytical mindExperience working with multiple data sets would be an advantagePositive attitude and a willingness to learn Please apply with an up to date CV today and someone from the team will be in touch!Randstad Business Support is acting as an Employment Business in relation to this vacancy.
Overview Contract: 3-6 months (with possibility of going permanent) Job Title: Bid Manager/Tender & Contracts ManagerLocation: Solihull, Birmingham (with opportunity to WFH 2-3 times per week)Salary: £50,000 pro rota (circa £25.00 per hour)We are delighted to be working in partnership with a marketing leading supply into the medical field. We are searching for a diligent and capable Bid Manager to fulfil a contract role with the possibility to go permanent. If you pride yourself on your ability to negotiate contracts and find the best tender agreements for your organisation this is the role for you. Responsibilities:Responsibility for coordination and management of the response and submission of all tenders and Request for Proposal (including framework offerings) across multiple franchises.Responsibility for development of bid text and content for response to tenders.Bid project management of all aspects of the bid response including coordination activities for pricing.Support in the development and maintenance of the Tender Library and standard collateral.Administration and management of all Framework pricing and Trust bands.Providing support with the implementation and development of tender and contract tools and templates.Delivery of continuous improvement of all tools and processes relating to tender management and processes.Offering contract management and pricing insights in relation to existing contracts and associated customer usage.Providing support in creating and utilizing tools for Commercial Analysis.Experience / Skills:Experience in a similar Tender Management / Sales support roleNHS Procurement processes knowledgeExperience in tender management within health care is requiredWillingness to learn/developHigh attention to detailStrong communication skills and strong writing/bid text authoring skillsExtremely capable at using Microsoft Excel and managing large volume of dataHighly disciplined individual who can work to deadlinesHighly organizedArticulate and numericalTeam player - diplomatic but also focused on hitting deadlines in high pressure environment Randstad Business Support acts as an employment business when supplying temporary staff and as an employment agency when introducing candidates for permanent employment with a client. Randstad Business Support is an equal opportunities employer and decisions are made on merits alone.
Overview Contract: 3-6 months (with possibility of going permanent) Job Title: Bid Manager/Tender & Contracts ManagerLocation: Solihull, Birmingham (with opportunity to WFH 2-3 times per week)Salary: £50,000 pro rota (circa £25.00 per hour)We are delighted to be working in partnership with a marketing leading supply into the medical field. We are searching for a diligent and capable Bid Manager to fulfil a contract role with the possibility to go permanent. If you pride yourself on your ability to negotiate contracts and find the best tender agreements for your organisation this is the role for you. Responsibilities:Responsibility for coordination and management of the response and submission of all tenders and Request for Proposal (including framework offerings) across multiple franchises.Responsibility for development of bid text and content for response to tenders.Bid project management of all aspects of the bid response including coordination activities for pricing.Support in the development and maintenance of the Tender Library and standard collateral.Administration and management of all Framework pricing and Trust bands.Providing support with the implementation and development of tender and contract tools and templates.Delivery of continuous improvement of all tools and processes relating to tender management and processes.Offering contract management and pricing insights in relation to existing contracts and associated customer usage.Providing support in creating and utilizing tools for Commercial Analysis.Experience / Skills:Experience in a similar Tender Management / Sales support roleNHS Procurement processes knowledgeExperience in tender management within health care is requiredWillingness to learn/developHigh attention to detailStrong communication skills and strong writing/bid text authoring skillsExtremely capable at using Microsoft Excel and managing large volume of dataHighly disciplined individual who can work to deadlinesHighly organizedArticulate and numericalTeam player - diplomatic but also focused on hitting deadlines in high pressure environment Randstad Business Support acts as an employment business when supplying temporary staff and as an employment agency when introducing candidates for permanent employment with a client. Randstad Business Support is an equal opportunities employer and decisions are made on merits alone.
Why work for this company? Our client discovers, develops, manufactures and commercializes medicines, vaccines and diagnostic products, which are complemented by bio-devices, genetic tests and a range of services. They serve veterinarians, livestock producers and people who raise and care for farm and companion animals in more than 100 countries. Company Profile 65+ years of experience in animal health Nearly $6 billion annual revenues 25 manufacturing sites around the world 10,000 employees worldwide of which 1,100 employees are committed to R&DJob Description The QC Analytical Chemist reports to the Quality Control Lead, and will be responsible for all QC test activities including but not limited to testing of Incoming materials, In Process Materials, Intermediate, API and Stability Sample, Method Transfer and Validation and Data Review. The role will maintain the Quality System for QC; ensuring that Standard Operating and Analytical Procedures are in place, adhered to and that compliance with cGMP is maintained through ongoing training and process review. This position is primarily an analytical laboratory function so will involve the majority of the time spent working in a laboratory. Responsibilities: Development, Validation and Transfer of Analytical Methods, including cleaning method validation and associated troubleshooting as required. Analytical support to include monitoring of production and analytical results throughout the technology transfer and process validation phases through to commercial manufacturing. Preparation & review of laboratory documentation (e.g. Method Transfer and Validation protocols and reports, SOP's, calibration procedures, Analytical Test Records and miscellaneous protocols). Testing of Raw Material, Intermediates, API's and materials associated with the reaction process and cleaning process in accordance with approved procedures including the stability testing program. Testing of Swab and Rinse samples and visual inspection of equipment after cleaning. Sampling and Testing of support utilities (Water, Nitrogen, Steam, Environmental Monitoring). Review and accuracy check of Analytical Data. Performing Own Training activities (reading acknowledgements, attendance at training events, online training completion). Active participation in laboratory Tier meetings. Active participation in problem solving, troubleshooting, laboratory investigations, compliance related activities, audit observations, continuous improvement activities and Lean Six Sigma/Operational Excellence activities. Participation in Instrumentation calibration & maintenance. Responsible for ensuring that laboratory equipment is maintained and functioning properly according to specifications. Laboratory system support (e.g. Maintain reference standards, retention samples, stability testing, vendor certification, Training system, HPLC & GC columns, Coordinate evacuations, shower checks, self-inspections, Quality and Safety inspections). Performing data trending. Record and update Laboratory metrics.Requirements: Bachelor of Science in Chemistry with experience in a laboratory environment. Method Validation, HPLC and GC proficiency essential. Recognised LSS Qualification (Yellow Belt, Green Belt, Black Belt) desirable. This position will require fluent use of Laboratory Software tools e.g. Empower 3, Trackwise, SAP, Document Management, Learning Management. This position will require fluent use of teleconferencing and Webex tools, as well as Sharepoint technologies, to share and manage information with Global QC Network and Quality Organization. Ability to develop and adhere to self-directed standard work. Demonstrated skills organizing and tracking data and documents. Proficient in English. Demonstrated capability to effectively apply knowledge, manage multiple activities simultaneously and balance priorities to deliver objectives. Demonstrated written and oral communication skills, as well as experience with presenting to leadership teams. Must have strong technical/analytical skills and demonstrated commitment to delivering results.Due to a high volume of applications only those progressing to the next stage will be contacted.Randstad encourage applications from individuals of all ages & backgrounds. Whilst appointments will be made on merit alone candidates must be able to prove their right to work in the UK or the Republic of Ireland (as relevant). Randstad acts as an employment agency for permanent recruitment & an employment business for temporary recruitment as defined by the Conduct of Employment Agencies & Employment Business Regulations 2003
Why work for this company? Our client discovers, develops, manufactures and commercializes medicines, vaccines and diagnostic products, which are complemented by bio-devices, genetic tests and a range of services. They serve veterinarians, livestock producers and people who raise and care for farm and companion animals in more than 100 countries. Company Profile 65+ years of experience in animal health Nearly $6 billion annual revenues 25 manufacturing sites around the world 10,000 employees worldwide of which 1,100 employees are committed to R&DJob Description The QC Analytical Chemist reports to the Quality Control Lead, and will be responsible for all QC test activities including but not limited to testing of Incoming materials, In Process Materials, Intermediate, API and Stability Sample, Method Transfer and Validation and Data Review. The role will maintain the Quality System for QC; ensuring that Standard Operating and Analytical Procedures are in place, adhered to and that compliance with cGMP is maintained through ongoing training and process review. This position is primarily an analytical laboratory function so will involve the majority of the time spent working in a laboratory. Responsibilities: Development, Validation and Transfer of Analytical Methods, including cleaning method validation and associated troubleshooting as required. Analytical support to include monitoring of production and analytical results throughout the technology transfer and process validation phases through to commercial manufacturing. Preparation & review of laboratory documentation (e.g. Method Transfer and Validation protocols and reports, SOP's, calibration procedures, Analytical Test Records and miscellaneous protocols). Testing of Raw Material, Intermediates, API's and materials associated with the reaction process and cleaning process in accordance with approved procedures including the stability testing program. Testing of Swab and Rinse samples and visual inspection of equipment after cleaning. Sampling and Testing of support utilities (Water, Nitrogen, Steam, Environmental Monitoring). Review and accuracy check of Analytical Data. Performing Own Training activities (reading acknowledgements, attendance at training events, online training completion). Active participation in laboratory Tier meetings. Active participation in problem solving, troubleshooting, laboratory investigations, compliance related activities, audit observations, continuous improvement activities and Lean Six Sigma/Operational Excellence activities. Participation in Instrumentation calibration & maintenance. Responsible for ensuring that laboratory equipment is maintained and functioning properly according to specifications. Laboratory system support (e.g. Maintain reference standards, retention samples, stability testing, vendor certification, Training system, HPLC & GC columns, Coordinate evacuations, shower checks, self-inspections, Quality and Safety inspections). Performing data trending. Record and update Laboratory metrics.Requirements: Bachelor of Science in Chemistry with experience in a laboratory environment. Method Validation, HPLC and GC proficiency essential. Recognised LSS Qualification (Yellow Belt, Green Belt, Black Belt) desirable. This position will require fluent use of Laboratory Software tools e.g. Empower 3, Trackwise, SAP, Document Management, Learning Management. This position will require fluent use of teleconferencing and Webex tools, as well as Sharepoint technologies, to share and manage information with Global QC Network and Quality Organization. Ability to develop and adhere to self-directed standard work. Demonstrated skills organizing and tracking data and documents. Proficient in English. Demonstrated capability to effectively apply knowledge, manage multiple activities simultaneously and balance priorities to deliver objectives. Demonstrated written and oral communication skills, as well as experience with presenting to leadership teams. Must have strong technical/analytical skills and demonstrated commitment to delivering results.Due to a high volume of applications only those progressing to the next stage will be contacted.Randstad encourage applications from individuals of all ages & backgrounds. Whilst appointments will be made on merit alone candidates must be able to prove their right to work in the UK or the Republic of Ireland (as relevant). Randstad acts as an employment agency for permanent recruitment & an employment business for temporary recruitment as defined by the Conduct of Employment Agencies & Employment Business Regulations 2003
Why work for this company?Our client discovers, develops, manufactures and commercialises medicines, vaccines and diagnostic products, which are complemented by bio-devices, genetic tests and a range of services. Company Profile:65+ years of experience in healthNearly $6 billion annual revenues25 manufacturing sites around the world10,000 employees worldwide of which 1,100 employees are committed to R&DThis role reports to the Electrical Lead and will assist with Engineering activities associated with the site's core process plant equipment. Primary accountabilities are Support the development of a Central Engineering Database and Centre of Excellence for API process plantEngineering oversight of process plant equipment Subject Matter Expert for Engineering Department for existing and new process plantSupport the development and delivery of process plant training modules for Engineering Technicians Support the scoping and early Engineering design of new process introductions and process improvement projectsApprove design deliverable and hand over documentation associated with process projectsUpdate and maintain relevant site Engineering standards & proceduresScope, develop and lead new projects related to process plant equipment improvements Ensure compliance with all relevant and regulatory policies Ensure that process plant equipment is maintained in accordance with vendor & legislative requirementsSupport the Safety Controls & Interlock strategy for the siteSupport the Asset Integrity strategy for the site with particular emphasis on process plantSupport the development of the site strategy for process plant equipment risk assessments and compliance with Machinery Directive guidelines The role will report to the site Electrical Lead and will have a strong relationship with the site Maintenance, Projects, Utilities, Operations, Quality and EHS functions.Responsibilities Compliance Ensure regulatory agency policies and standards for plant equipment are fully complied with including Quality, EHS, FDA, HPRA, EPA, HSAInterface with regulatory agencies during site audits and walkdowns Work closely with EHS, Operations, Utilities, Automation and Maintenance personnel to ensure equipment is safe to operate & maintainUtilise the site Change Control process for all site projects ensuring that all changes are captured and assessed/tested/closed out in a timely mannerEnsure safety files for process plant equipment are maintained and updated as requiredAct as Client representative for interactions with project delivery teams and OEM's in relation to design, Machinery Directive and risk assessments for process plant equipmentAttend Factory Acceptance Tests at OEM manufacturing facilitiesEnsure Pre-Startup Safety Reviews are completed prior to operation and use of existing, modified or new equipment. Availability of SystemsWork closely with Maintenance, Utilities & Operations to ensure process plant equipment reviews and upgrades are implemented in a timely manner to avoid production downtimes Collaboration and InfluencingWork with the Restart Project Team to execute a timely start-up to the Wicklow facilityCollaborate closely with EHS, Quality, Operations and Maintenance in supporting problem investigation Act as client Engineering representative on capital projects associated with process plant Be a champion for Health & Safety. Education and Experience Bachelor's Degree in Mechanical, Chemical, Process or Electrical Engineering, honors grade.5 years plus experience in the GMP manufacturing environment.Understanding of GMP and the Quality standards required in the API Manufacturing sector.Experience of the Operation and Maintenance of Manufacturing process systems within a regulated environmentFamiliarity with Machinery Directive legislation & implementation within an ATEX environment would be an advantage. Technical skillsFamiliar with the operation of API process plant including centrifuge, drying, separation, filtration and condensing equipmentExperience of leading root cause investigations, deviation reports and CAPA implementationRandstad encourage applications from individuals of all ages & backgrounds. Whilst appointments will be made on merit alone candidates must be able to prove their right to work in the UK or the Republic of Ireland (as relevant). Randstad acts as an employment agency for permanent recruitment & an employment business for temporary recruitment as defined by the Conduct of Employment Agencies & Employment Business Regulations 2003
Why work for this company?Our client discovers, develops, manufactures and commercialises medicines, vaccines and diagnostic products, which are complemented by bio-devices, genetic tests and a range of services. Company Profile:65+ years of experience in healthNearly $6 billion annual revenues25 manufacturing sites around the world10,000 employees worldwide of which 1,100 employees are committed to R&DThis role reports to the Electrical Lead and will assist with Engineering activities associated with the site's core process plant equipment. Primary accountabilities are Support the development of a Central Engineering Database and Centre of Excellence for API process plantEngineering oversight of process plant equipment Subject Matter Expert for Engineering Department for existing and new process plantSupport the development and delivery of process plant training modules for Engineering Technicians Support the scoping and early Engineering design of new process introductions and process improvement projectsApprove design deliverable and hand over documentation associated with process projectsUpdate and maintain relevant site Engineering standards & proceduresScope, develop and lead new projects related to process plant equipment improvements Ensure compliance with all relevant and regulatory policies Ensure that process plant equipment is maintained in accordance with vendor & legislative requirementsSupport the Safety Controls & Interlock strategy for the siteSupport the Asset Integrity strategy for the site with particular emphasis on process plantSupport the development of the site strategy for process plant equipment risk assessments and compliance with Machinery Directive guidelines The role will report to the site Electrical Lead and will have a strong relationship with the site Maintenance, Projects, Utilities, Operations, Quality and EHS functions.Responsibilities Compliance Ensure regulatory agency policies and standards for plant equipment are fully complied with including Quality, EHS, FDA, HPRA, EPA, HSAInterface with regulatory agencies during site audits and walkdowns Work closely with EHS, Operations, Utilities, Automation and Maintenance personnel to ensure equipment is safe to operate & maintainUtilise the site Change Control process for all site projects ensuring that all changes are captured and assessed/tested/closed out in a timely mannerEnsure safety files for process plant equipment are maintained and updated as requiredAct as Client representative for interactions with project delivery teams and OEM's in relation to design, Machinery Directive and risk assessments for process plant equipmentAttend Factory Acceptance Tests at OEM manufacturing facilitiesEnsure Pre-Startup Safety Reviews are completed prior to operation and use of existing, modified or new equipment. Availability of SystemsWork closely with Maintenance, Utilities & Operations to ensure process plant equipment reviews and upgrades are implemented in a timely manner to avoid production downtimes Collaboration and InfluencingWork with the Restart Project Team to execute a timely start-up to the Wicklow facilityCollaborate closely with EHS, Quality, Operations and Maintenance in supporting problem investigation Act as client Engineering representative on capital projects associated with process plant Be a champion for Health & Safety. Education and Experience Bachelor's Degree in Mechanical, Chemical, Process or Electrical Engineering, honors grade.5 years plus experience in the GMP manufacturing environment.Understanding of GMP and the Quality standards required in the API Manufacturing sector.Experience of the Operation and Maintenance of Manufacturing process systems within a regulated environmentFamiliarity with Machinery Directive legislation & implementation within an ATEX environment would be an advantage. Technical skillsFamiliar with the operation of API process plant including centrifuge, drying, separation, filtration and condensing equipmentExperience of leading root cause investigations, deviation reports and CAPA implementationRandstad encourage applications from individuals of all ages & backgrounds. Whilst appointments will be made on merit alone candidates must be able to prove their right to work in the UK or the Republic of Ireland (as relevant). Randstad acts as an employment agency for permanent recruitment & an employment business for temporary recruitment as defined by the Conduct of Employment Agencies & Employment Business Regulations 2003
Are you an experienced Translational Science Lead? We are recruiting for a consumer healthcare client at their site based in High-Wycombe on a contract basis for 6 months initially. The successful candidate will be supporting the shaping of future clinical protocols. This is a part time role, working 25 hours a week, outside IR35. Responsibilities:Work with R&D team and franchise team to shape short and long term KOL advocacy strategy in EMEARepresentation at key congresses and roundtables with KOLsPublication strategyWork with R&D team to influence shaping of future clinical protocolsDevelopment of key scientific claimsCapability plan to activate in key marketsExperience: Masters Degree or EquivalentTeamwork experienceProject management skillsOral & written communication skillsOrganisational & multi-tasking skillsKnowledge of guidelines and practice of EMEA regions Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.Candidates must be eligible to live and work in the UK.For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.
Are you an experienced Translational Science Lead? We are recruiting for a consumer healthcare client at their site based in High-Wycombe on a contract basis for 6 months initially. The successful candidate will be supporting the shaping of future clinical protocols. This is a part time role, working 25 hours a week, outside IR35. Responsibilities:Work with R&D team and franchise team to shape short and long term KOL advocacy strategy in EMEARepresentation at key congresses and roundtables with KOLsPublication strategyWork with R&D team to influence shaping of future clinical protocolsDevelopment of key scientific claimsCapability plan to activate in key marketsExperience: Masters Degree or EquivalentTeamwork experienceProject management skillsOral & written communication skillsOrganisational & multi-tasking skillsKnowledge of guidelines and practice of EMEA regions Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.Candidates must be eligible to live and work in the UK.For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.
Are you an experienced Regulatory Affairs Professional? We are recruiting for an EMEA Regulatory Professional to work for a Pharmaceutical client at their site based in High-Wycombe on a contract basis for 12 months initially. The successful candidate will be able to support the regional regulatory strategy for products in their oncology pipeline, preferably with experience of clinical trial applications, scientific advice procedures, paediatric investigational plans or EU marketing authorisation applications and variations. Responsibilities:Input in development, post-approval and Life cycle managementAdvise the Regulatory team on applicable regulatory requirements, project specific regulatory issues as assignedHave an understanding of the regional regulatory environment, and able to develop understand competitor intelligence and therapeutic areaLiaison with Regulatory Agencies and Local Operating CompaniesDraft cover letters for Regulatory Agency communicationAssist in the preparation of meetings with Regulatory AgenciesLiaise with LOCs, track and respond to queries in a timely mannerAssist in development of processes related to regulatory submissionsDraft and review some document content (depending on level of regulatory knowledge / expertise)Provide input to documentation to ensure they thoroughly and accurately answer the questions being posedTrack dates of submissions and Regulatory Agency responsesClinical Trial Applications (CTA)Review protocols and ensure alignment with regulatory requirementsAdvise team on required documents and submission strategies in preparation of CTAsEnsure CTA submission packages are complete and available according to agreed timelinesReview and approve clinical trial supply plansMarketing Authorization Applications (MAA)Provide regulatory support throughout registration processProvide regulatory support throughout life-cycle managementAdvise team on required documents and submission strategies in preparation of MAA as assigned (in collaboration with LOCs as appropriate)Assist with timely MAA availability, ensure that all document components are in place on time, identify and track critical path activitiesAssist with submission and acceptance of MAAEnsure country-specific submission packages are made available to the LOCs in accordance with agreed plansExperience: University degree - medical or paramedical (pharmacy, biology, veterinary etc.), or equivalent by experienceExperience in regulatory affairsTeamwork experienceProject management skillsOral & written communication skillsOrganization & multi-tasking skillsKnowledge of the regulatory environment, guidelines and practice of EMEA regions Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.Candidates must be eligible to live and work in the UK.For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.
Are you an experienced Regulatory Affairs Professional? We are recruiting for an EMEA Regulatory Professional to work for a Pharmaceutical client at their site based in High-Wycombe on a contract basis for 12 months initially. The successful candidate will be able to support the regional regulatory strategy for products in their oncology pipeline, preferably with experience of clinical trial applications, scientific advice procedures, paediatric investigational plans or EU marketing authorisation applications and variations. Responsibilities:Input in development, post-approval and Life cycle managementAdvise the Regulatory team on applicable regulatory requirements, project specific regulatory issues as assignedHave an understanding of the regional regulatory environment, and able to develop understand competitor intelligence and therapeutic areaLiaison with Regulatory Agencies and Local Operating CompaniesDraft cover letters for Regulatory Agency communicationAssist in the preparation of meetings with Regulatory AgenciesLiaise with LOCs, track and respond to queries in a timely mannerAssist in development of processes related to regulatory submissionsDraft and review some document content (depending on level of regulatory knowledge / expertise)Provide input to documentation to ensure they thoroughly and accurately answer the questions being posedTrack dates of submissions and Regulatory Agency responsesClinical Trial Applications (CTA)Review protocols and ensure alignment with regulatory requirementsAdvise team on required documents and submission strategies in preparation of CTAsEnsure CTA submission packages are complete and available according to agreed timelinesReview and approve clinical trial supply plansMarketing Authorization Applications (MAA)Provide regulatory support throughout registration processProvide regulatory support throughout life-cycle managementAdvise team on required documents and submission strategies in preparation of MAA as assigned (in collaboration with LOCs as appropriate)Assist with timely MAA availability, ensure that all document components are in place on time, identify and track critical path activitiesAssist with submission and acceptance of MAAEnsure country-specific submission packages are made available to the LOCs in accordance with agreed plansExperience: University degree - medical or paramedical (pharmacy, biology, veterinary etc.), or equivalent by experienceExperience in regulatory affairsTeamwork experienceProject management skillsOral & written communication skillsOrganization & multi-tasking skillsKnowledge of the regulatory environment, guidelines and practice of EMEA regions Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.Candidates must be eligible to live and work in the UK.For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.
Are you looking for a new role as a Mechanical Design Engineer? Do you want to work for a business that is growing at a rapid pace with lots of opportunity for the future? If so, this could be the role for you!As the Extrusion and Food Process Engineer, you will be the first member of the Bioprocess Engineering group that will be responsible for the design and implementation of our clients first-of-its-kind manufacturing processes and facilities. This position will design, build, test, and scale-up mechanical process equipment for cold extrusion and other specialty process applications. The role will require a strong background in machine design with the ultimate goal of deploying this equipment in our future commercial-scale manufacturing facilities and bringing strategic differentiation to our production platform.This role is offered on a full time permanent basis, with a business that also offers lots of other benefits that will make you feel truly at home whilst at work. Responsibilities:Identify and define process and system requirements by understanding and challenging product formulation and processing assumptions with the aim of implementing robust unit operations and increasing overall operational efficiency and effectivenessPartner with internal and external teams to solve technical challenges and identify opportunities for process improvement and cost savingsManaging relationships with strategic partners, engineering firms, equipment vendors and technology partnersSpecify project scope, timelines, resourcing and budget needsDevelop project capital requirements and objectives through creation of proposals and plans with breakdown structures (WBS)Track and complete projects by managing schedules, costs and specificationsSome travel may be required to collaborator and manufacturing sitesAdditional ad hoc duties as required by the companyExperience: Ability to apply mechanical engineering principles and computer-aided methods to machine design and fabricationMechanical aptitude and comfortable with working directly on mechanical equipmentEfficient Design of Experiments and statistical analysis of experimental and characterization/validation dataUnderstanding of aseptic techniques and control of microbial contaminationAbility to partner cross-functionally on proprietary process technologies, while also developing and leveraging successful external contacts and relationshipsProject engineering and managementStrong scientific and technical writing and presentations.Detail oriented with excellent verbal and written communication skillsInnovative and creative thinking and willing to challenge established methods and beliefsSelf-starter with a strong bias for action and ability for problem-solving and trouble-shootingRandstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.Candidates must be eligible to live and work in the UK.For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.
Are you looking for a new role as a Mechanical Design Engineer? Do you want to work for a business that is growing at a rapid pace with lots of opportunity for the future? If so, this could be the role for you!As the Extrusion and Food Process Engineer, you will be the first member of the Bioprocess Engineering group that will be responsible for the design and implementation of our clients first-of-its-kind manufacturing processes and facilities. This position will design, build, test, and scale-up mechanical process equipment for cold extrusion and other specialty process applications. The role will require a strong background in machine design with the ultimate goal of deploying this equipment in our future commercial-scale manufacturing facilities and bringing strategic differentiation to our production platform.This role is offered on a full time permanent basis, with a business that also offers lots of other benefits that will make you feel truly at home whilst at work. Responsibilities:Identify and define process and system requirements by understanding and challenging product formulation and processing assumptions with the aim of implementing robust unit operations and increasing overall operational efficiency and effectivenessPartner with internal and external teams to solve technical challenges and identify opportunities for process improvement and cost savingsManaging relationships with strategic partners, engineering firms, equipment vendors and technology partnersSpecify project scope, timelines, resourcing and budget needsDevelop project capital requirements and objectives through creation of proposals and plans with breakdown structures (WBS)Track and complete projects by managing schedules, costs and specificationsSome travel may be required to collaborator and manufacturing sitesAdditional ad hoc duties as required by the companyExperience: Ability to apply mechanical engineering principles and computer-aided methods to machine design and fabricationMechanical aptitude and comfortable with working directly on mechanical equipmentEfficient Design of Experiments and statistical analysis of experimental and characterization/validation dataUnderstanding of aseptic techniques and control of microbial contaminationAbility to partner cross-functionally on proprietary process technologies, while also developing and leveraging successful external contacts and relationshipsProject engineering and managementStrong scientific and technical writing and presentations.Detail oriented with excellent verbal and written communication skillsInnovative and creative thinking and willing to challenge established methods and beliefsSelf-starter with a strong bias for action and ability for problem-solving and trouble-shootingRandstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.Candidates must be eligible to live and work in the UK.For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.
Are you looking for a new role as a Bioprocess Design Engineer? Do you want to work for a business that is growing at a rapid pace with lots of opportunity for the future? If so, this could be the role for you!This position will focus on the design, building, testing, and scale-up of the upstream unit operations centered around animal cell culture and recovery operations. The role will require a strong background in bioreactor design, theory and operation as well as bioprocess equipment and facility design in general. Initially, this Engineer will assist the design and fabrication of prototypes for testing but with the ultimate goal of scaling up this equipment for our future cost-effective commercial-scale manufacturing facilities. This role is offered on a full time permanent basis, with a business that also offers lots of other benefits that will make you feel truly at home whilst at work. Responsibilities:Work with bioprocess development colleagues to identify and define process and system requirements and translate into detailed equipment specificationsDesign and manage fabrication of the upstream process equipment towards robust and highly-dependable aseptic processing by using the appropriate design standards, level of control and automationDesign the upstream portion of manufacturing to ensure reliable and safe operation while also producing a high-quality product free of contaminants while also achieving overall operational efficiencyGenerate process and cost models to identify key drivers of cost and efficiencyManaging relationships while working with strategic partners, engineering firms, equipment vendors and technology partners towards the design, construct and commission Ivy Farm's manufacturing facilitiesSpecify project scope, timelines, resourcing and budget needsDevelop project capital requirements and objectives through creation of proposals and plans with breakdown structures (WBS)Track and complete projects by managing schedules, costs and specificationsPartner with internal and external teams to solve technical challenges and identify opportunities for process improvement and cost savingsSome travel may be required to collaborator and manufacturing sitesQualifications: Bachelor's degree or higher in Engineering, Food Science or related fieldMaster's degree preferred3+ years of related experience in bioprocess equipment design, modeling, facility design, construction, start up and/or operationExperience: Demonstrated strong technical background and ability to lead technically driven projectsAbility to apply biochemical engineering principles and computer-aided methods to equipment design, fabrication, and operationUnderstanding of aseptic techniques and control of microbial contaminationKnowledge of process and facility design and economicsProject engineering and management, including direct management of architectural and engineering design firms, equipment vendors and construction contractorsAbility to partner cross-functionally on proprietary process technologies, while also developing and leveraging successful external contacts and relationshipsMechanical aptitude and comfortable with working directly on process equipment and control systemsStrong scientific and technical writing and presentationsDetail oriented with excellent verbal and written communication skillsInnovative and creative thinking and willing to challenge established methods and beliefsSelf-starter with a strong bias for action and ability for problem-solving and trouble-shooting Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.Candidates must be eligible to live and work in the UK.For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.
Are you looking for a new role as a Bioprocess Design Engineer? Do you want to work for a business that is growing at a rapid pace with lots of opportunity for the future? If so, this could be the role for you!This position will focus on the design, building, testing, and scale-up of the upstream unit operations centered around animal cell culture and recovery operations. The role will require a strong background in bioreactor design, theory and operation as well as bioprocess equipment and facility design in general. Initially, this Engineer will assist the design and fabrication of prototypes for testing but with the ultimate goal of scaling up this equipment for our future cost-effective commercial-scale manufacturing facilities. This role is offered on a full time permanent basis, with a business that also offers lots of other benefits that will make you feel truly at home whilst at work. Responsibilities:Work with bioprocess development colleagues to identify and define process and system requirements and translate into detailed equipment specificationsDesign and manage fabrication of the upstream process equipment towards robust and highly-dependable aseptic processing by using the appropriate design standards, level of control and automationDesign the upstream portion of manufacturing to ensure reliable and safe operation while also producing a high-quality product free of contaminants while also achieving overall operational efficiencyGenerate process and cost models to identify key drivers of cost and efficiencyManaging relationships while working with strategic partners, engineering firms, equipment vendors and technology partners towards the design, construct and commission Ivy Farm's manufacturing facilitiesSpecify project scope, timelines, resourcing and budget needsDevelop project capital requirements and objectives through creation of proposals and plans with breakdown structures (WBS)Track and complete projects by managing schedules, costs and specificationsPartner with internal and external teams to solve technical challenges and identify opportunities for process improvement and cost savingsSome travel may be required to collaborator and manufacturing sitesQualifications: Bachelor's degree or higher in Engineering, Food Science or related fieldMaster's degree preferred3+ years of related experience in bioprocess equipment design, modeling, facility design, construction, start up and/or operationExperience: Demonstrated strong technical background and ability to lead technically driven projectsAbility to apply biochemical engineering principles and computer-aided methods to equipment design, fabrication, and operationUnderstanding of aseptic techniques and control of microbial contaminationKnowledge of process and facility design and economicsProject engineering and management, including direct management of architectural and engineering design firms, equipment vendors and construction contractorsAbility to partner cross-functionally on proprietary process technologies, while also developing and leveraging successful external contacts and relationshipsMechanical aptitude and comfortable with working directly on process equipment and control systemsStrong scientific and technical writing and presentationsDetail oriented with excellent verbal and written communication skillsInnovative and creative thinking and willing to challenge established methods and beliefsSelf-starter with a strong bias for action and ability for problem-solving and trouble-shooting Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.Candidates must be eligible to live and work in the UK.For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.
Why work for this company?Our client discovers, develops, manufactures and commercialises medicines, vaccines and diagnostic products, which are complemented by bio-devices, genetic tests and a range of services. They serve veterinarians, livestock producers and people who raise and care for farm and companion animals in more than 100 countries.Company Profile:65+ years of experience in animal healthNearly $6 billion annual revenues25 manufacturing sites around the world10,000 employees worldwide of which 1,100 employees are committed to R&DResponsibilities:Ensures manufacturing operations are continually supported and maintained in compliance with all quality, safety and environmental regulations.Technical transfer, Scale-up & Installation of new processes & new unit operations onto and with-in the plant.Support Process & Facility start-ups, initial campaigns & process optimisation.Complete detailed Equipment and Process assessments.Project Management of wide scope cross functional projects.Application of Six Sigma and Lean methodologies when undertaking projects and coaching others in use of these tools as part of their application.Ensure campaign preparations for individual processes are achieved to facilitate on‐time campaign start‐up and adherence of agreed production rate.Takes ownership for assigned process steps and provides process technical support as required.Lead cross functional investigations within operations. Use lean six sigma tools to drive root cause analysis and CAPA completion.The preparation and routine review of Batch Records, Cleaning Procedures, Equipment Operating Procedures, Standard Operating Procedures, Protocols and Summary Reports. These updates include actively making changes to drive improvements, increase in RFT and decrease in deviations.The development and update of control system recipes.Participation in audits, quality monitoring inspections and self-inspections as required. Lead cycle time reduction initiatives.Participation and driving of Continuous Improvement Activities.Lead EHS activities including Process HAZOP.Preparation of change control packages.Skills and Experience:3 to 5 years of experience in a technical role in the API industry.Degree in Chemical/Process Engineering or Chemistry.Technical skills and competencies:Strong leadership, communication, decision making and problem solving skills.Experience with 6 sigma or other operational excellence tools.Experience of working in a cross functional team in a highly regulated environment.Experience of technology transfer and a new product/equipment start-up.An understanding of computer control systems, P.I.D loops and interlock devices.Ability to manage multiple projects simultaneously and prioritise work, goals and tasks in accordance with division and corporate objectives.Randstad encourage applications from individuals of all ages & backgrounds. Whilst appointments will be made on merit alone candidates must be able to prove their right to work in the UK or the Republic of Ireland (as relevant). Randstad acts as an employment agency for permanent recruitment & an employment business for temporary recruitment as defined by the Conduct of Employment Agencies & Employment Business Regulations 2003
Why work for this company?Our client discovers, develops, manufactures and commercialises medicines, vaccines and diagnostic products, which are complemented by bio-devices, genetic tests and a range of services. They serve veterinarians, livestock producers and people who raise and care for farm and companion animals in more than 100 countries.Company Profile:65+ years of experience in animal healthNearly $6 billion annual revenues25 manufacturing sites around the world10,000 employees worldwide of which 1,100 employees are committed to R&DResponsibilities:Ensures manufacturing operations are continually supported and maintained in compliance with all quality, safety and environmental regulations.Technical transfer, Scale-up & Installation of new processes & new unit operations onto and with-in the plant.Support Process & Facility start-ups, initial campaigns & process optimisation.Complete detailed Equipment and Process assessments.Project Management of wide scope cross functional projects.Application of Six Sigma and Lean methodologies when undertaking projects and coaching others in use of these tools as part of their application.Ensure campaign preparations for individual processes are achieved to facilitate on‐time campaign start‐up and adherence of agreed production rate.Takes ownership for assigned process steps and provides process technical support as required.Lead cross functional investigations within operations. Use lean six sigma tools to drive root cause analysis and CAPA completion.The preparation and routine review of Batch Records, Cleaning Procedures, Equipment Operating Procedures, Standard Operating Procedures, Protocols and Summary Reports. These updates include actively making changes to drive improvements, increase in RFT and decrease in deviations.The development and update of control system recipes.Participation in audits, quality monitoring inspections and self-inspections as required. Lead cycle time reduction initiatives.Participation and driving of Continuous Improvement Activities.Lead EHS activities including Process HAZOP.Preparation of change control packages.Skills and Experience:3 to 5 years of experience in a technical role in the API industry.Degree in Chemical/Process Engineering or Chemistry.Technical skills and competencies:Strong leadership, communication, decision making and problem solving skills.Experience with 6 sigma or other operational excellence tools.Experience of working in a cross functional team in a highly regulated environment.Experience of technology transfer and a new product/equipment start-up.An understanding of computer control systems, P.I.D loops and interlock devices.Ability to manage multiple projects simultaneously and prioritise work, goals and tasks in accordance with division and corporate objectives.Randstad encourage applications from individuals of all ages & backgrounds. Whilst appointments will be made on merit alone candidates must be able to prove their right to work in the UK or the Republic of Ireland (as relevant). Randstad acts as an employment agency for permanent recruitment & an employment business for temporary recruitment as defined by the Conduct of Employment Agencies & Employment Business Regulations 2003
Role PurposeThe QA Specialist will play an active role in support of the general site quality system, and in addition, all 3rd party, regulatory, technology transfer, operational and audit initiatives.The QA Specialist will support the ongoing maintenance and continuous improvement of existing QA process and SOPs across all disciplines.Reporting StructureReporting to the Quality Operations Manager. Duties & ResponsibilitiesSupport the vendor management process to include vendor assessments, auditing and qualification. Support and participate in supplier change notification process for the site.Partake and contribute to internal and external audits and conduct on site audits as required. Analyse audit outcomes and implement appropriate corrective procedures.Prepare Quality agreements with required Vendors.Oversee and support site Material requirement specifications. Support site risk management procedures.Support change management, deviations and CAPA systems as required.Manage specific projects that may arise, in a timely and efficient manner. Support ongoing running and maintenance and additional requirements for Supplier management module of the Electronic tracking system ETS.Participate in ongoing set up of electronic systems where required.POSITION SPECIFICATIONQualifications, Experience, Skills, Knowledge and AttributesThird level Degree in a life science discipline.At least 2-3 years Biotech/Pharmaceutical QA experience with a strong knowledge of cGMP.Experience of interaction with cross-departmental teams.Excellent interpersonal and communication skills, meticulous eye for detail.Self-motivation.Computer literate.Strong time management awareness and the ability to drive projects forward. Randstad Financial & Professional encourage applications from individuals of all ages & backgrounds. Appointment will be made on merit alone but candidates must be able to demonstrate their ability to work in the UK. Randstad Financial & Professional acts as an employment agency for permanent recruitment & an employment business for temporary recruitment as defined by the Conduct of Employment Agencies & Employment Business Regulations 2003
Role PurposeThe QA Specialist will play an active role in support of the general site quality system, and in addition, all 3rd party, regulatory, technology transfer, operational and audit initiatives.The QA Specialist will support the ongoing maintenance and continuous improvement of existing QA process and SOPs across all disciplines.Reporting StructureReporting to the Quality Operations Manager. Duties & ResponsibilitiesSupport the vendor management process to include vendor assessments, auditing and qualification. Support and participate in supplier change notification process for the site.Partake and contribute to internal and external audits and conduct on site audits as required. Analyse audit outcomes and implement appropriate corrective procedures.Prepare Quality agreements with required Vendors.Oversee and support site Material requirement specifications. Support site risk management procedures.Support change management, deviations and CAPA systems as required.Manage specific projects that may arise, in a timely and efficient manner. Support ongoing running and maintenance and additional requirements for Supplier management module of the Electronic tracking system ETS.Participate in ongoing set up of electronic systems where required.POSITION SPECIFICATIONQualifications, Experience, Skills, Knowledge and AttributesThird level Degree in a life science discipline.At least 2-3 years Biotech/Pharmaceutical QA experience with a strong knowledge of cGMP.Experience of interaction with cross-departmental teams.Excellent interpersonal and communication skills, meticulous eye for detail.Self-motivation.Computer literate.Strong time management awareness and the ability to drive projects forward. Randstad Financial & Professional encourage applications from individuals of all ages & backgrounds. Appointment will be made on merit alone but candidates must be able to demonstrate their ability to work in the UK. Randstad Financial & Professional acts as an employment agency for permanent recruitment & an employment business for temporary recruitment as defined by the Conduct of Employment Agencies & Employment Business Regulations 2003
JOB TITLE: Technical Support CoordinatorLOCATION: MaidenheadDURATION: 6 Months Temp to permPAY: £25K Per annumThe Client Specialising in the emerging market of medical devices and diagnostics agents. Our client has a large product area in Diabetes, Arthritis, Spesis, Pregnancy and many more. They are a global client that makes and sells technologically advanced devices that are used within hospitals, homes and other private groups. Key Responsibilities:Responsible for the front and back office administrative and logistical support for the Capital Equipment Service Team. The team is responsible for installation, upgrading, repair and preventive maintenance of all capital equipment part of the company's product portfolio in compliance with the Regulatory and Quality policies and procedures. Candidate Requirements:Knowledge of warehouse executions is a plusStrong verbal and written interpersonal, communication & organisational skills with ability to effectively communicate at multiple levels in the organisation.Some analytical ability, originality and/or ingenuity required. Strong organisational and follow-up skills, as well as attention to detailExperience working in a broader enterprise/cross-division business unit model preferred.Ability to work in a highly matrixed and geographically diverse business environment.Ability to work within a team and as an individual contributor in a fast-paced, changing environment. English is a must, any additional European languages is a plusComputer skills: MSOffice, SAP, is desiredAbility to be flexible and respond to situations at short noticeMultitasks, prioritises and meets deadlines in timely manner Ability to work with little supervision within a team and as an individual contributor in a fast-paced, changing environment.Ability to leverage and/or engage others to accomplish projectsAbility to maintain regular and predictable attendance.Ability to travel approximately 10%, including internationally for training purposes.Meet and exceed customer expectations by striving for the greatest possible reliability and quality in our products, processes and systems through accountable, competent, and professional support.Familiarity with cath lab and operating room procedures and protocol would be a plusAbility to be flexible and respond to situations at short noticeAble to work independently in a fast environment with little supervisionTeam spirit is a mustRandstad Business Support is acting as an Employment Business in relation to this vacancy.
JOB TITLE: Technical Support CoordinatorLOCATION: MaidenheadDURATION: 6 Months Temp to permPAY: £25K Per annumThe Client Specialising in the emerging market of medical devices and diagnostics agents. Our client has a large product area in Diabetes, Arthritis, Spesis, Pregnancy and many more. They are a global client that makes and sells technologically advanced devices that are used within hospitals, homes and other private groups. Key Responsibilities:Responsible for the front and back office administrative and logistical support for the Capital Equipment Service Team. The team is responsible for installation, upgrading, repair and preventive maintenance of all capital equipment part of the company's product portfolio in compliance with the Regulatory and Quality policies and procedures. Candidate Requirements:Knowledge of warehouse executions is a plusStrong verbal and written interpersonal, communication & organisational skills with ability to effectively communicate at multiple levels in the organisation.Some analytical ability, originality and/or ingenuity required. Strong organisational and follow-up skills, as well as attention to detailExperience working in a broader enterprise/cross-division business unit model preferred.Ability to work in a highly matrixed and geographically diverse business environment.Ability to work within a team and as an individual contributor in a fast-paced, changing environment. English is a must, any additional European languages is a plusComputer skills: MSOffice, SAP, is desiredAbility to be flexible and respond to situations at short noticeMultitasks, prioritises and meets deadlines in timely manner Ability to work with little supervision within a team and as an individual contributor in a fast-paced, changing environment.Ability to leverage and/or engage others to accomplish projectsAbility to maintain regular and predictable attendance.Ability to travel approximately 10%, including internationally for training purposes.Meet and exceed customer expectations by striving for the greatest possible reliability and quality in our products, processes and systems through accountable, competent, and professional support.Familiarity with cath lab and operating room procedures and protocol would be a plusAbility to be flexible and respond to situations at short noticeAble to work independently in a fast environment with little supervisionTeam spirit is a mustRandstad Business Support is acting as an Employment Business in relation to this vacancy.
Are you looking for a new role as a Qualified Person? Do you want to work at our clients third-party logistics site that handles consumer goods? If so, this could be the role for you!You will be responsible for batch certification of human medicinal products alongside our clients existing QP. The products in scope are OTC and GSL oral dosage forms, imported from outside the EU and released into the UK and NI. There are typically 4 batches per month, and some undergo secondary packaging prior to release.The successful candidate will also be required to use their expertise in support of the on-site QA Team in various aspects of the quality system, such as investigations, risk assessments and quality improvements.This role is offered initially on a 12 month contract basis, working part time. Hours per week / month can be discussed. This will include one physical visit to site per month to fulfil duties as outlined in the QP Code of Conduct.Responsibilities:Certified to act as a QP in the UK and on Professional Body QP eligibility listProven experience acting as a releasing QP for commercial products (preferably involving commercial secondary packaging and / or importation)Good knowledge in the application of the following, as applicable to medicines for human use: The UK Human Medicines Regulations (SI 2012 1916), MHRA Orange and Green Guides, EU Directive 2001/83/EC, EU GMDP Guidance (Eudralex)Knowledge of compendial requirements, analytical techniques and laboratory instrumentationSupport QA Team with quality investigations, changes, quality risk assessments, implementation of CAPA, quality improvement projects, quality training, audits of third partiesSupport with regulatory inspections of the site.Provide advice and guidance regarding pharmaceutical regulations and input on proposed licence updates or variations Build collaborative relationships with internal and external partners, such as the current contract QP, site RP and the UK MAH / UK RPPosses energy and drive for GMDP compliance in a collaborative and practical mannerExcellent communication and interpersonal skills, able to interact with various departments and sites where requiredSome flexibility in availability in order to be able to support urgent needs as they arise.Experience and qualifications required: Certified to act as a QP in the UK and on Professional Body QP eligibility listManufacturing and testing of oral liquids and solids, and nasal inhalation dosage formsImportation of medicines from MRA and third countriesAuditing contract testing laboratories and manufacturing sites for EU GMP complianceUse of electronic systems, such as Veeva (eQMS, GTRAQ) and EnoviaImplementation of or major changes to quality systems and processes Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.Candidates must be eligible to live and work in the UK.For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.
Are you looking for a new role as a Qualified Person? Do you want to work at our clients third-party logistics site that handles consumer goods? If so, this could be the role for you!You will be responsible for batch certification of human medicinal products alongside our clients existing QP. The products in scope are OTC and GSL oral dosage forms, imported from outside the EU and released into the UK and NI. There are typically 4 batches per month, and some undergo secondary packaging prior to release.The successful candidate will also be required to use their expertise in support of the on-site QA Team in various aspects of the quality system, such as investigations, risk assessments and quality improvements.This role is offered initially on a 12 month contract basis, working part time. Hours per week / month can be discussed. This will include one physical visit to site per month to fulfil duties as outlined in the QP Code of Conduct.Responsibilities:Certified to act as a QP in the UK and on Professional Body QP eligibility listProven experience acting as a releasing QP for commercial products (preferably involving commercial secondary packaging and / or importation)Good knowledge in the application of the following, as applicable to medicines for human use: The UK Human Medicines Regulations (SI 2012 1916), MHRA Orange and Green Guides, EU Directive 2001/83/EC, EU GMDP Guidance (Eudralex)Knowledge of compendial requirements, analytical techniques and laboratory instrumentationSupport QA Team with quality investigations, changes, quality risk assessments, implementation of CAPA, quality improvement projects, quality training, audits of third partiesSupport with regulatory inspections of the site.Provide advice and guidance regarding pharmaceutical regulations and input on proposed licence updates or variations Build collaborative relationships with internal and external partners, such as the current contract QP, site RP and the UK MAH / UK RPPosses energy and drive for GMDP compliance in a collaborative and practical mannerExcellent communication and interpersonal skills, able to interact with various departments and sites where requiredSome flexibility in availability in order to be able to support urgent needs as they arise.Experience and qualifications required: Certified to act as a QP in the UK and on Professional Body QP eligibility listManufacturing and testing of oral liquids and solids, and nasal inhalation dosage formsImportation of medicines from MRA and third countriesAuditing contract testing laboratories and manufacturing sites for EU GMP complianceUse of electronic systems, such as Veeva (eQMS, GTRAQ) and EnoviaImplementation of or major changes to quality systems and processes Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.Candidates must be eligible to live and work in the UK.For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.
JOB TITLE: StatisticianCONTRACT LENGTH: 12 Months (Potential Perm)PAY RATE: £25K to £35K Per Annum (DOE)LOCATION: Witney - Office based Purpose of this role To support clinical study activities and the development of products and testing procedures through the application of statistical methods to products and processes. Your new responsibilities Demonstrate the ability to apply knowledge of statistical concepts into practice.Provide statistical support in the development of new products through to launch under direction of senior colleagues.Support the statistical development, evaluation and verification of stability, calibration and product release methods by useof appropriate statistical methodologies.Analyse results from clinical studies aimed at demonstrating product efficacy and safety.Maintain appropriate records of activities and tasks carried out in compliance with the appropriate Quality Systems.Provide technical support to clinical studies, product development and/or Operations activities to ensure continued smooth running and interaction between departments.Must take responsibility for their individual tasks and understand the impact of their actions on the overall business and other functions.Ideal background and education The minimum education is a BSc in Mathematics or Statistics (or equivalent) to ensure that the jobholder has sufficient technical knowledge to understand and use statistics. Must be accurate and organised in work approach and have good attention to detail in order to ensure that data and analyses are accurate and meet the requirements of the project. Must have good written communication skills to be able to prepare appropriate reports. Must have good oral communication skills to be able to provide management with feedback on development needs and report and present progress. Must have a basic technical and theoretical understanding of projects to be able to extrapolate initial results to predict outcomes and take appropriate actions. Experience in SAS is preferred, must have experience in using word processor applications and spreadsheets to perform suitable data analysis and report writing.Randstad Business Support is acting as an Employment Business in relation to this vacancy.
JOB TITLE: StatisticianCONTRACT LENGTH: 12 Months (Potential Perm)PAY RATE: £25K to £35K Per Annum (DOE)LOCATION: Witney - Office based Purpose of this role To support clinical study activities and the development of products and testing procedures through the application of statistical methods to products and processes. Your new responsibilities Demonstrate the ability to apply knowledge of statistical concepts into practice.Provide statistical support in the development of new products through to launch under direction of senior colleagues.Support the statistical development, evaluation and verification of stability, calibration and product release methods by useof appropriate statistical methodologies.Analyse results from clinical studies aimed at demonstrating product efficacy and safety.Maintain appropriate records of activities and tasks carried out in compliance with the appropriate Quality Systems.Provide technical support to clinical studies, product development and/or Operations activities to ensure continued smooth running and interaction between departments.Must take responsibility for their individual tasks and understand the impact of their actions on the overall business and other functions.Ideal background and education The minimum education is a BSc in Mathematics or Statistics (or equivalent) to ensure that the jobholder has sufficient technical knowledge to understand and use statistics. Must be accurate and organised in work approach and have good attention to detail in order to ensure that data and analyses are accurate and meet the requirements of the project. Must have good written communication skills to be able to prepare appropriate reports. Must have good oral communication skills to be able to provide management with feedback on development needs and report and present progress. Must have a basic technical and theoretical understanding of projects to be able to extrapolate initial results to predict outcomes and take appropriate actions. Experience in SAS is preferred, must have experience in using word processor applications and spreadsheets to perform suitable data analysis and report writing.Randstad Business Support is acting as an Employment Business in relation to this vacancy.
Why work for this company?Our client discovers, develops, manufactures and commercialises medicines, vaccines and diagnostic products, which are complemented by bio-devices, genetic tests and a range of services. Company Profile:65+ years of experience in healthNearly $6 billion annual revenues25 manufacturing sites around the world10,000 employees worldwide of which 1,100 employees are committed to R&DPosition Summary *This is an interim position (Initial 6 month contract) The incumbent leads a team of production operators at the Wicklow site to achieve agreed levels of schedule adherence, customer service, regulatory compliance and financial targets. The role will report to the Operations Leader and take responsibility and ownership together with the Manufacturing Operations Manager for all day to day activities associated with Operations. The overarching goal is to ensure the smooth running of operations and the proper and timely resolution of any problems that may arise. Position Responsibilities Ensures that all process operations are performed in conformance with site, divisional and corporate quality, environmental and safety standards and that all related incidents are thoroughly investigated and corrected.Is responsible for the ongoing training and development of operational personnel.Manages shift personnel to ensure production targets are met including balancing manpower, managing holidays, managing O/THave overall responsibility for all cGMP matters within the area under their authority, and in particular for:Monitoring cGMP performance in their area of responsibility.Ensuring colleagues working on activities or within areas that impact on the identity, strength, quality, purity, safety and effectiveness of our products follow all applicable procedures and are appropriately trained for the task.As required supports the Operations technical group in process and cleaning deviation investigations. Ensure that all EHS policies for their area are complied with by:Provision of up to date procedures and training for all aspects of operations.Risk assessment of new operationsInvestigations and RCA of incidents and near misses and timely implementation of CAPAs together with the Manufacturing Operations Manager.Implements procedures for tracking schedule adherence performance against plans together with the Manufacturing Operations Manager. When results exceed tolerance, he/she is responsible together with the Manufacturing Operations for reporting the reason and applying appropriate tools to prevent re occurrence.Creating a culture of problem-solving to drive to the root cause and ensuring implementation of related corrective/preventative actions.Provides support to the Operations Lead in ensuring adherence to all site performance and behavioural standards for all operational colleagues and initiates disciplinary procedures as necessary.Be responsible for the coaching and development of operational colleagues.Organisational Relationships Direct line report to the Operations Lead.This position will need to achieve results through colleagues with both a direct and indirect reporting relationship as part of the site recommissioning core project team through to commercialisation. This position will need to interact frequently with site leadership to assure operational goals and objectives are met.All employees are expected to model the company's Core Beliefs. Each team member can influence and bring knowledge to their work teams during their day-to-day interactions. Education and Experience Degree in Chemistry or Process / Chemical Engineering Experience in a manufacturing environment in the API industry with a minimum of 3 to 5 years at management level. Technical Skills and Competencies required Strong leadership, communication, decision making and problem-solving skills. A demonstrated ability to motivate and coach others to achieve results.Experience with 6 sigma or other operational excellence toolsExperience of working in a cross functional team in a highly regulated environment.Experience of technology transfer and new product/equipment start-up. Ability to manage multiple projects simultaneously and prioritise work, goals and tasks in accordance with division and corporate objectivesProactive approach to dealing with customer inquiries and requests. Randstad encourage applications from individuals of all ages & backgrounds. Whilst appointments will be made on merit alone candidates must be able to prove their right to work in the UK or the Republic of Ireland (as relevant). Randstad acts as an employment agency for permanent recruitment & an employment business for temporary recruitment as defined by the Conduct of Employment Agencies & Employment Business Regulations 2003
Why work for this company?Our client discovers, develops, manufactures and commercialises medicines, vaccines and diagnostic products, which are complemented by bio-devices, genetic tests and a range of services. Company Profile:65+ years of experience in healthNearly $6 billion annual revenues25 manufacturing sites around the world10,000 employees worldwide of which 1,100 employees are committed to R&DPosition Summary *This is an interim position (Initial 6 month contract) The incumbent leads a team of production operators at the Wicklow site to achieve agreed levels of schedule adherence, customer service, regulatory compliance and financial targets. The role will report to the Operations Leader and take responsibility and ownership together with the Manufacturing Operations Manager for all day to day activities associated with Operations. The overarching goal is to ensure the smooth running of operations and the proper and timely resolution of any problems that may arise. Position Responsibilities Ensures that all process operations are performed in conformance with site, divisional and corporate quality, environmental and safety standards and that all related incidents are thoroughly investigated and corrected.Is responsible for the ongoing training and development of operational personnel.Manages shift personnel to ensure production targets are met including balancing manpower, managing holidays, managing O/THave overall responsibility for all cGMP matters within the area under their authority, and in particular for:Monitoring cGMP performance in their area of responsibility.Ensuring colleagues working on activities or within areas that impact on the identity, strength, quality, purity, safety and effectiveness of our products follow all applicable procedures and are appropriately trained for the task.As required supports the Operations technical group in process and cleaning deviation investigations. Ensure that all EHS policies for their area are complied with by:Provision of up to date procedures and training for all aspects of operations.Risk assessment of new operationsInvestigations and RCA of incidents and near misses and timely implementation of CAPAs together with the Manufacturing Operations Manager.Implements procedures for tracking schedule adherence performance against plans together with the Manufacturing Operations Manager. When results exceed tolerance, he/she is responsible together with the Manufacturing Operations for reporting the reason and applying appropriate tools to prevent re occurrence.Creating a culture of problem-solving to drive to the root cause and ensuring implementation of related corrective/preventative actions.Provides support to the Operations Lead in ensuring adherence to all site performance and behavioural standards for all operational colleagues and initiates disciplinary procedures as necessary.Be responsible for the coaching and development of operational colleagues.Organisational Relationships Direct line report to the Operations Lead.This position will need to achieve results through colleagues with both a direct and indirect reporting relationship as part of the site recommissioning core project team through to commercialisation. This position will need to interact frequently with site leadership to assure operational goals and objectives are met.All employees are expected to model the company's Core Beliefs. Each team member can influence and bring knowledge to their work teams during their day-to-day interactions. Education and Experience Degree in Chemistry or Process / Chemical Engineering Experience in a manufacturing environment in the API industry with a minimum of 3 to 5 years at management level. Technical Skills and Competencies required Strong leadership, communication, decision making and problem-solving skills. A demonstrated ability to motivate and coach others to achieve results.Experience with 6 sigma or other operational excellence toolsExperience of working in a cross functional team in a highly regulated environment.Experience of technology transfer and new product/equipment start-up. Ability to manage multiple projects simultaneously and prioritise work, goals and tasks in accordance with division and corporate objectivesProactive approach to dealing with customer inquiries and requests. Randstad encourage applications from individuals of all ages & backgrounds. Whilst appointments will be made on merit alone candidates must be able to prove their right to work in the UK or the Republic of Ireland (as relevant). Randstad acts as an employment agency for permanent recruitment & an employment business for temporary recruitment as defined by the Conduct of Employment Agencies & Employment Business Regulations 2003
JOB TITLE: Procurement ManagerSTART DATE: ASAPContract: 12 Months - Perm PotentialPAY RATE: £75,000+ Per Annum LOCATION: Witney, Oxfordshire - Hybrid The Client Specialising in the emerging market of medical devices and diagnostics agents. Our client has a large product area in Diabetes, Arthritis, Spesis, Pregnancy and many more. They are a global client that makes and sells technologically advanced devices that are used within hospitals, homes and other private groups. The Project Due to continued business growth and internal progression, we have an exciting opportunity for a Procurement Manager to join our team based in Witney, Oxfordshire. Your experience Degree qualified and bring a breadth of experience across both operational and strategic procurement in the manufacturing environment. You have CIPS and/or Project Management certifications are advantageous but not essential.You are a self-starter/results focused individual who brings the ability to build effective relationships with colleagues and other functional teams, and excellent interdisciplinary, intercultural, influence/negotiation and networking skills. You are adept at managing change, with experience gained in a large sized organisation, and comfortable managing teams at the strategic level. Your new responsibilities The Procurement Manager will be accountable for leading and developing the procurement process to support both UK and Ireland operations. Driving ownership and accountability in your team, the focus will be on supporting the ongoing development of both process and people, whilst delivering on large upcoming tender opportunities, on-time, and on-budget.Responsible for the management of strategic relationships, both internally and externally, you will be experienced in both Direct Material and Indirect procurement, and able to implement the business vision for Indirect Procurement.Leading a team of 5 direct reports, you will develop and deploy our vision and strategy with amulti-year roadmap to establish the function in the European sites and ensure implementation and leverage of best practices and compliance across all purchasing areas.You will continually look for opportunities for cost reductions, cost avoidance and provision of overall value improvements, whilst measuring and tracking team performance.Focusing on motivating factors to develop the strong team already in place in Witney, you will establish processes and standards that will elevate the procurement team. With a focus on talent development, coaching, and mentoring, you will build skills in the people of the team and support continued delivery of business objectives.Randstad Business Support is acting as an Employment Business in relation to this vacancy.
JOB TITLE: Procurement ManagerSTART DATE: ASAPContract: 12 Months - Perm PotentialPAY RATE: £75,000+ Per Annum LOCATION: Witney, Oxfordshire - Hybrid The Client Specialising in the emerging market of medical devices and diagnostics agents. Our client has a large product area in Diabetes, Arthritis, Spesis, Pregnancy and many more. They are a global client that makes and sells technologically advanced devices that are used within hospitals, homes and other private groups. The Project Due to continued business growth and internal progression, we have an exciting opportunity for a Procurement Manager to join our team based in Witney, Oxfordshire. Your experience Degree qualified and bring a breadth of experience across both operational and strategic procurement in the manufacturing environment. You have CIPS and/or Project Management certifications are advantageous but not essential.You are a self-starter/results focused individual who brings the ability to build effective relationships with colleagues and other functional teams, and excellent interdisciplinary, intercultural, influence/negotiation and networking skills. You are adept at managing change, with experience gained in a large sized organisation, and comfortable managing teams at the strategic level. Your new responsibilities The Procurement Manager will be accountable for leading and developing the procurement process to support both UK and Ireland operations. Driving ownership and accountability in your team, the focus will be on supporting the ongoing development of both process and people, whilst delivering on large upcoming tender opportunities, on-time, and on-budget.Responsible for the management of strategic relationships, both internally and externally, you will be experienced in both Direct Material and Indirect procurement, and able to implement the business vision for Indirect Procurement.Leading a team of 5 direct reports, you will develop and deploy our vision and strategy with amulti-year roadmap to establish the function in the European sites and ensure implementation and leverage of best practices and compliance across all purchasing areas.You will continually look for opportunities for cost reductions, cost avoidance and provision of overall value improvements, whilst measuring and tracking team performance.Focusing on motivating factors to develop the strong team already in place in Witney, you will establish processes and standards that will elevate the procurement team. With a focus on talent development, coaching, and mentoring, you will build skills in the people of the team and support continued delivery of business objectives.Randstad Business Support is acting as an Employment Business in relation to this vacancy.
As the Global Labelling Lead, you would be responsible for developing the strategy and leading the development and update of core labelling documents and for overseeing implementation at a local and regional level. Specifically:Leading the development of a Target Label Profile for a development productLeading the development of the internal process for TLPLeading the Core Data Sheet updates for several approved products What You'll DoCreate and update core labelling documents:Lead timely creation/management of regulatory compliant, competitive and up to date core labelling documents throughout the product life cycle Lead cross functional product Global Labelling Team to reach consensus on core labelling matters, accurately capture and communicate decisions, and obtain endorsement by senior management To be considered for this role, you will have:5 years pharmaceutical/ biotechnology industry regulatory experience, including regulatory labellingSolid knowledge and understanding of applicable regulations, pharmacology, medicine, pharmacovigilance and drug developmentProven experience with document management and regulatory tracking systemsProven ability to successfully understand regulatory implications of product strategy with regard to the product label, assessment and practical management of associated impactsMust Have Core Data Sheet experince 6 Month Contract, based in Maidenhead. Start June 2022.Full time - 37.5 hours per weekUmbrella or PAYE. Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.Candidates must be eligible to live and work in the UK.For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.
As the Global Labelling Lead, you would be responsible for developing the strategy and leading the development and update of core labelling documents and for overseeing implementation at a local and regional level. Specifically:Leading the development of a Target Label Profile for a development productLeading the development of the internal process for TLPLeading the Core Data Sheet updates for several approved products What You'll DoCreate and update core labelling documents:Lead timely creation/management of regulatory compliant, competitive and up to date core labelling documents throughout the product life cycle Lead cross functional product Global Labelling Team to reach consensus on core labelling matters, accurately capture and communicate decisions, and obtain endorsement by senior management To be considered for this role, you will have:5 years pharmaceutical/ biotechnology industry regulatory experience, including regulatory labellingSolid knowledge and understanding of applicable regulations, pharmacology, medicine, pharmacovigilance and drug developmentProven experience with document management and regulatory tracking systemsProven ability to successfully understand regulatory implications of product strategy with regard to the product label, assessment and practical management of associated impactsMust Have Core Data Sheet experince 6 Month Contract, based in Maidenhead. Start June 2022.Full time - 37.5 hours per weekUmbrella or PAYE. Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.Candidates must be eligible to live and work in the UK.For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.
Duties & Responsibilities Perform testing of in-process, final product, and stability of drug substance and drug product samples using a suite of protein-specific analytical methods (CGE, SEC-HPLC, cIEF, ELISA) and general analytical methods (appearance analysis, pH, conductivity, etc.). Microbiological analysis including Environmental Monitoring, Endotoxin and Bioburden testing, growth promotion, and other associated tests. Support the technical transfer of analytical test methods to and from the Tullamore facility. ● Creation and revision of documents including test methods, SOPs, material requirement specifications, forms, and other quality system documentation to allow the execution of the analysis in a GMP environment. This will include trending data, monitoring Out of Specifications and participating in laboratory investigations. Work closely with the process development group to support the development of a robust manufacturing process. Work closely with specialist contract testing service providers to ensure excellent collaboration is maintained throughout the project. Support raw material testing (and outsourcing activities) to E.P./USP monographs when required for GMP manufacture. Input into the identification of equipment requirements and work with vendors to ensure execution of all deliverables, including equipment qualification and validation. Provide technical reports upon completion of QC projects. Participate in Quality and Safety regulatory audits. Qualifications, Experience, Skills, Knowledge and Attributes BSc, MSc in a relevant discipline (e.g. biochemistry, chemistry, process engineering) or equivalent experience. Minimum 1-year relevant experience in a GMP laboratory environment. Experience of the test methods commonly used in the analysis of proteins, including but not limited to ELISA, SEC-HPLC, CE-SDS, cIEF, and protein content by UV-Vis spectrophotometry. Knowledge of protein characterisation techniques is also desirable. Experience with Qualification and Validation of test methods. Proven ability to work independently in a laboratory. Ability to learn quickly and take responsibility for tasks/projects. Highly organised and structured approach to task completion. ● Excellent verbal and written communication skills, including ability to present work in clear, concise reports or presentations.Randstad Financial & Professional encourage applications from individuals of all ages & backgrounds. Appointment will be made on merit alone but candidates must be able to demonstrate their ability to work in the UK. Randstad Financial & Professional acts as an employment agency for permanent recruitment & an employment business for temporary recruitment as defined by the Conduct of Employment Agencies & Employment Business Regulations 2003
Duties & Responsibilities Perform testing of in-process, final product, and stability of drug substance and drug product samples using a suite of protein-specific analytical methods (CGE, SEC-HPLC, cIEF, ELISA) and general analytical methods (appearance analysis, pH, conductivity, etc.). Microbiological analysis including Environmental Monitoring, Endotoxin and Bioburden testing, growth promotion, and other associated tests. Support the technical transfer of analytical test methods to and from the Tullamore facility. ● Creation and revision of documents including test methods, SOPs, material requirement specifications, forms, and other quality system documentation to allow the execution of the analysis in a GMP environment. This will include trending data, monitoring Out of Specifications and participating in laboratory investigations. Work closely with the process development group to support the development of a robust manufacturing process. Work closely with specialist contract testing service providers to ensure excellent collaboration is maintained throughout the project. Support raw material testing (and outsourcing activities) to E.P./USP monographs when required for GMP manufacture. Input into the identification of equipment requirements and work with vendors to ensure execution of all deliverables, including equipment qualification and validation. Provide technical reports upon completion of QC projects. Participate in Quality and Safety regulatory audits. Qualifications, Experience, Skills, Knowledge and Attributes BSc, MSc in a relevant discipline (e.g. biochemistry, chemistry, process engineering) or equivalent experience. Minimum 1-year relevant experience in a GMP laboratory environment. Experience of the test methods commonly used in the analysis of proteins, including but not limited to ELISA, SEC-HPLC, CE-SDS, cIEF, and protein content by UV-Vis spectrophotometry. Knowledge of protein characterisation techniques is also desirable. Experience with Qualification and Validation of test methods. Proven ability to work independently in a laboratory. Ability to learn quickly and take responsibility for tasks/projects. Highly organised and structured approach to task completion. ● Excellent verbal and written communication skills, including ability to present work in clear, concise reports or presentations.Randstad Financial & Professional encourage applications from individuals of all ages & backgrounds. Appointment will be made on merit alone but candidates must be able to demonstrate their ability to work in the UK. Randstad Financial & Professional acts as an employment agency for permanent recruitment & an employment business for temporary recruitment as defined by the Conduct of Employment Agencies & Employment Business Regulations 2003
Job Title: Training and Support SpecialistLocation: Remote - Midlands preferable Type: Part-time - 22 hours - 3 days per week (flexible)Pay rate: £17.00Driving Licence Essential Are you experienced in training or coaching? Are you a great communicator who enjoys supporting others? Do you enjoy having autonomy and flexibility in your work?Randstad are recruiting on behalf of a global healthcare organisation for a Training and Support Specialist. In this role, you will an advocate of the product portfolio, representing the company training a mix of clients and customers on how to get the best out of their product. The ideal candidate will come from some kind of training background - preferably from the healthcare / well-being industry. Key Responsibilities:* Product training for healthcare professionals* Engage with nurses and patients to organise virtual training sessions* Plan your own diary - good time management is essential * Support sales cycles for target secondary care accounts with regard to training and support* Maintain the necessary contacts and working relationships with internal and external customers* Travel to client visits to put on training sessions ad hoc when needed Key Requirements:* Experience in a training / coaching role (nurses, PTs, teachers etc.)* Great communication skills and ability to build rapport with key stakeholders* Excellent time management and self-motivation* Experience communicating with Healthcare Professionals is preferable * Education around sciences or healthcare is preferable This is a fantastic opportunity to work in a role where you have flexibility and autonomy over your own schedule. If this sounds like you, please apply with an up to date CV today! Randstad Business Support is acting as an Employment Business in relation to this vacancy.
Job Title: Training and Support SpecialistLocation: Remote - Midlands preferable Type: Part-time - 22 hours - 3 days per week (flexible)Pay rate: £17.00Driving Licence Essential Are you experienced in training or coaching? Are you a great communicator who enjoys supporting others? Do you enjoy having autonomy and flexibility in your work?Randstad are recruiting on behalf of a global healthcare organisation for a Training and Support Specialist. In this role, you will an advocate of the product portfolio, representing the company training a mix of clients and customers on how to get the best out of their product. The ideal candidate will come from some kind of training background - preferably from the healthcare / well-being industry. Key Responsibilities:* Product training for healthcare professionals* Engage with nurses and patients to organise virtual training sessions* Plan your own diary - good time management is essential * Support sales cycles for target secondary care accounts with regard to training and support* Maintain the necessary contacts and working relationships with internal and external customers* Travel to client visits to put on training sessions ad hoc when needed Key Requirements:* Experience in a training / coaching role (nurses, PTs, teachers etc.)* Great communication skills and ability to build rapport with key stakeholders* Excellent time management and self-motivation* Experience communicating with Healthcare Professionals is preferable * Education around sciences or healthcare is preferable This is a fantastic opportunity to work in a role where you have flexibility and autonomy over your own schedule. If this sounds like you, please apply with an up to date CV today! Randstad Business Support is acting as an Employment Business in relation to this vacancy.
Role PurposeThis role within the Quality Control group will support all microbiological testing carried out by the analytical group- utilities and method qualification and routine monitoring, In-process, Drug Substance and Drug Product testing, stability testing and raw material testing.Reporting StructureReporting to The Quality Control Manager. Duties & ResponsibilitiesProvide Microbiological support to the siteDevelop, maintain and update microbiological methods, specifications and SOP's in compliance with quality and regulatory requirements to allow the execution of the analysis in a GMP environment. This will include trending data, monitoring Out of Specifications and participating in laboratory investigations.Testing of In-process, Drug Substance and Drug Product Batches manufactured.Co-ordinating all site Utilities testing-environmental monitoring and water testing programmes.Lead all environmental investigations, root cause analysis, and report close out.Lead monthly environmental review meetings and present all relevant trends to a cross departmental team.Provide annual contamination control training to all personnel. Provide aseptic technique training to all new employees.Validation of microbiological methods e.g. bioburden and endotoxin.Support autoclave validation programme.Stability testing of Drug Substance and Drug Product BatchesParticipate in Quality and Safety regulatory audits.Support raw material testing when required for GMP manufactureInput into the identification of equipment requirements and work with vendors to ensure execution of all deliverables, including equipment qualification and validation.Troubleshooting equipment and techniques within the Analytical team.Participation in other projects/duties as defined by the Quality Director POSITION SPECIFICATIONQualifications, Experience, Skills, Knowledge and AttributesThird level degree in a life Science discipline2-5 years' experience in a microbiology role with relevant experience in environmental monitoring and utilities testing, bioburden testing and endotoxin testing. Experience in validation of microbiological methods is also required. Strong analytical and technical skills Ability to learn quickly and take responsibility for tasks/projects.Highly organised and structured approach to task completion.Strong time management awareness and the ability to drive projects forward.Excellent verbal and written communication skills, including ability to present work in clear, concise reports or presentations. Randstad Financial & Professional encourage applications from individuals of all ages & backgrounds. Appointment will be made on merit alone but candidates must be able to demonstrate their ability to work in the UK. Randstad Financial & Professional acts as an employment agency for permanent recruitment & an employment business for temporary recruitment as defined by the Conduct of Employment Agencies & Employment Business Regulations 2003
Role PurposeThis role within the Quality Control group will support all microbiological testing carried out by the analytical group- utilities and method qualification and routine monitoring, In-process, Drug Substance and Drug Product testing, stability testing and raw material testing.Reporting StructureReporting to The Quality Control Manager. Duties & ResponsibilitiesProvide Microbiological support to the siteDevelop, maintain and update microbiological methods, specifications and SOP's in compliance with quality and regulatory requirements to allow the execution of the analysis in a GMP environment. This will include trending data, monitoring Out of Specifications and participating in laboratory investigations.Testing of In-process, Drug Substance and Drug Product Batches manufactured.Co-ordinating all site Utilities testing-environmental monitoring and water testing programmes.Lead all environmental investigations, root cause analysis, and report close out.Lead monthly environmental review meetings and present all relevant trends to a cross departmental team.Provide annual contamination control training to all personnel. Provide aseptic technique training to all new employees.Validation of microbiological methods e.g. bioburden and endotoxin.Support autoclave validation programme.Stability testing of Drug Substance and Drug Product BatchesParticipate in Quality and Safety regulatory audits.Support raw material testing when required for GMP manufactureInput into the identification of equipment requirements and work with vendors to ensure execution of all deliverables, including equipment qualification and validation.Troubleshooting equipment and techniques within the Analytical team.Participation in other projects/duties as defined by the Quality Director POSITION SPECIFICATIONQualifications, Experience, Skills, Knowledge and AttributesThird level degree in a life Science discipline2-5 years' experience in a microbiology role with relevant experience in environmental monitoring and utilities testing, bioburden testing and endotoxin testing. Experience in validation of microbiological methods is also required. Strong analytical and technical skills Ability to learn quickly and take responsibility for tasks/projects.Highly organised and structured approach to task completion.Strong time management awareness and the ability to drive projects forward.Excellent verbal and written communication skills, including ability to present work in clear, concise reports or presentations. Randstad Financial & Professional encourage applications from individuals of all ages & backgrounds. Appointment will be made on merit alone but candidates must be able to demonstrate their ability to work in the UK. Randstad Financial & Professional acts as an employment agency for permanent recruitment & an employment business for temporary recruitment as defined by the Conduct of Employment Agencies & Employment Business Regulations 2003
Role PurposeThis role within the Quality Control group will support all microbiological testing carried out by the analytical group- utilities and method qualification and routine monitoring, In-process, Drug Substance and Drug Product testing, stability testing and raw material testing.Reporting StructureReporting to The Quality Control Manager. Duties & ResponsibilitiesProvide Microbiological support to the siteDevelop, maintain and update microbiological methods, specifications and SOP's in compliance with quality and regulatory requirements to allow the execution of the analysis in a GMP environment. This will include trending data, monitoring Out of Specifications and participating in laboratory investigations.Testing of In-process, Drug Substance and Drug Product Batches manufactured.Co-ordinating all site Utilities testing-environmental monitoring and water testing programmes.Lead all environmental investigations, root cause analysis, and report close out.Lead monthly environmental review meetings and present all relevant trends to a cross departmental team.Provide annual contamination control training to all personnel. Provide aseptic technique training to all new employees.Validation of microbiological methods e.g. bioburden and endotoxin.Support autoclave validation programme.Stability testing of Drug Substance and Drug Product BatchesParticipate in Quality and Safety regulatory audits.Support raw material testing when required for GMP manufactureInput into the identification of equipment requirements and work with vendors to ensure execution of all deliverables, including equipment qualification and validation.Troubleshooting equipment and techniques within the Analytical team.Participation in other projects/duties as defined by the Quality Director POSITION SPECIFICATIONQualifications, Experience, Skills, Knowledge and AttributesThird level degree in a life Science discipline2-5 years' experience in a microbiology role with relevant experience in environmental monitoring and utilities testing, bioburden testing and endotoxin testing. Experience in validation of microbiological methods is also required. Strong analytical and technical skills Ability to learn quickly and take responsibility for tasks/projects.Highly organised and structured approach to task completion.Strong time management awareness and the ability to drive projects forward.Excellent verbal and written communication skills, including ability to present work in clear, concise reports or presentations. Randstad Financial & Professional encourage applications from individuals of all ages & backgrounds. Appointment will be made on merit alone but candidates must be able to demonstrate their ability to work in the UK. Randstad Financial & Professional acts as an employment agency for permanent recruitment & an employment business for temporary recruitment as defined by the Conduct of Employment Agencies & Employment Business Regulations 2003
Role PurposeThis role within the Quality Control group will support all microbiological testing carried out by the analytical group- utilities and method qualification and routine monitoring, In-process, Drug Substance and Drug Product testing, stability testing and raw material testing.Reporting StructureReporting to The Quality Control Manager. Duties & ResponsibilitiesProvide Microbiological support to the siteDevelop, maintain and update microbiological methods, specifications and SOP's in compliance with quality and regulatory requirements to allow the execution of the analysis in a GMP environment. This will include trending data, monitoring Out of Specifications and participating in laboratory investigations.Testing of In-process, Drug Substance and Drug Product Batches manufactured.Co-ordinating all site Utilities testing-environmental monitoring and water testing programmes.Lead all environmental investigations, root cause analysis, and report close out.Lead monthly environmental review meetings and present all relevant trends to a cross departmental team.Provide annual contamination control training to all personnel. Provide aseptic technique training to all new employees.Validation of microbiological methods e.g. bioburden and endotoxin.Support autoclave validation programme.Stability testing of Drug Substance and Drug Product BatchesParticipate in Quality and Safety regulatory audits.Support raw material testing when required for GMP manufactureInput into the identification of equipment requirements and work with vendors to ensure execution of all deliverables, including equipment qualification and validation.Troubleshooting equipment and techniques within the Analytical team.Participation in other projects/duties as defined by the Quality Director POSITION SPECIFICATIONQualifications, Experience, Skills, Knowledge and AttributesThird level degree in a life Science discipline2-5 years' experience in a microbiology role with relevant experience in environmental monitoring and utilities testing, bioburden testing and endotoxin testing. Experience in validation of microbiological methods is also required. Strong analytical and technical skills Ability to learn quickly and take responsibility for tasks/projects.Highly organised and structured approach to task completion.Strong time management awareness and the ability to drive projects forward.Excellent verbal and written communication skills, including ability to present work in clear, concise reports or presentations. Randstad Financial & Professional encourage applications from individuals of all ages & backgrounds. Appointment will be made on merit alone but candidates must be able to demonstrate their ability to work in the UK. Randstad Financial & Professional acts as an employment agency for permanent recruitment & an employment business for temporary recruitment as defined by the Conduct of Employment Agencies & Employment Business Regulations 2003
Our Client is a leading developer, manufacturer and marketer of healthcare products. Originally established in 1976 to serve the renal care market in Ireland, Our Client evolved over the years under indigenous Irish ownership until its sale in 2006 to the Wockhardt Group, an Indian global pharmaceutical and biotechnology company headquartered in Mumbai, India. Wockhardt employs over 7,000 people across 27 nationalities with a presence in the USA, UK, Ireland, Switzerland, France, Mexico, Russia and many other countries. It has manufacturing and research facilities in India, the USA and UK and a manufacturing facility in Ireland.Key areas of responsibility (include but not limited to): Undergo on-going training for analytical test methods, GLP/GMP requirements and Health and Safety/Manual Handling as required.Carry out routine testing of materials/products as directed by Laboratory Supervisors/Managers.Prepare such reagents and standards as are needed to carry out the above testing. Label these materials and document the preparation as required.Provide test data and results to the Laboratory Supervisor. Report any Deviations or Out of Specification/Out of Expectation results observed.Keep Retain Samples of the above materials and transfer them to the Retain Area. Maintain this area in a clean and orderly manner.Maintain the laboratory premises and equipment in a clean and safe manner. Report any problems/defects immediately they are noticed.Remove reagents from the lab as they reach their expiry date. When fully trained in a test method or the use of a Laboratory instrument, assist in the training of other analysts in the use of these methods/instruments.When fully trained in a test method, the analyst may check and sign another analyst's notebook.Assist in the training of less experienced analysts.Other duties as required. Key Requirements: Educated Degree level in Chemistry or other appropriate disciplineExcellent organisational and time-management skills.Ability to leverage/collaborate effectively with internal and external stakeholdersExperience in HPLC and GC would be advantageous.Experience in stability systems would be advantageous.Must have excellent computer skills.Excellent written and verbal communication and interpersonal skills.Strong problem-solver.Resourceful.Independent.Critical thinker.Comfortable working in a busy, fast paced regulated manufacturing environment.Comfortable working in a professional, team based environment. Randstad Financial & Professional encourage applications from individuals of all ages & backgrounds. Appointment will be made on merit alone but candidates must be able to demonstrate their ability to work in the UK. Randstad Financial & Professional acts as an employment agency for permanent recruitment & an employment business for temporary recruitment as defined by the Conduct of Employment Agencies & Employment Business Regulations 2003
Our Client is a leading developer, manufacturer and marketer of healthcare products. Originally established in 1976 to serve the renal care market in Ireland, Our Client evolved over the years under indigenous Irish ownership until its sale in 2006 to the Wockhardt Group, an Indian global pharmaceutical and biotechnology company headquartered in Mumbai, India. Wockhardt employs over 7,000 people across 27 nationalities with a presence in the USA, UK, Ireland, Switzerland, France, Mexico, Russia and many other countries. It has manufacturing and research facilities in India, the USA and UK and a manufacturing facility in Ireland.Key areas of responsibility (include but not limited to): Undergo on-going training for analytical test methods, GLP/GMP requirements and Health and Safety/Manual Handling as required.Carry out routine testing of materials/products as directed by Laboratory Supervisors/Managers.Prepare such reagents and standards as are needed to carry out the above testing. Label these materials and document the preparation as required.Provide test data and results to the Laboratory Supervisor. Report any Deviations or Out of Specification/Out of Expectation results observed.Keep Retain Samples of the above materials and transfer them to the Retain Area. Maintain this area in a clean and orderly manner.Maintain the laboratory premises and equipment in a clean and safe manner. Report any problems/defects immediately they are noticed.Remove reagents from the lab as they reach their expiry date. When fully trained in a test method or the use of a Laboratory instrument, assist in the training of other analysts in the use of these methods/instruments.When fully trained in a test method, the analyst may check and sign another analyst's notebook.Assist in the training of less experienced analysts.Other duties as required. Key Requirements: Educated Degree level in Chemistry or other appropriate disciplineExcellent organisational and time-management skills.Ability to leverage/collaborate effectively with internal and external stakeholdersExperience in HPLC and GC would be advantageous.Experience in stability systems would be advantageous.Must have excellent computer skills.Excellent written and verbal communication and interpersonal skills.Strong problem-solver.Resourceful.Independent.Critical thinker.Comfortable working in a busy, fast paced regulated manufacturing environment.Comfortable working in a professional, team based environment. Randstad Financial & Professional encourage applications from individuals of all ages & backgrounds. Appointment will be made on merit alone but candidates must be able to demonstrate their ability to work in the UK. Randstad Financial & Professional acts as an employment agency for permanent recruitment & an employment business for temporary recruitment as defined by the Conduct of Employment Agencies & Employment Business Regulations 2003