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      • queenborough, south east
      • permanent
      • £45,000 - £55,000 per year
      • randstad cpe
      Quality Specialist required by my client, a Pharmaceutical Manufacturing business based in Kent. You will manage QMS System Owner for all Deviations, CAPAs, Audits, PQRs, ComplaintsCustomer first line quality contact. Attend customer meetings and work with the business to implement customer requirementsTo work with QPs and Development to assist in driving continuous quality improvements.To be considered for the role of Quality Specialist, you will:Demonstrate a good understanding of GMP for IMP and developmentEducated to Science degree or equivalentERP software experience preferable.This is a permanent role, based in Queenborough. Relocation assistance available 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.
      Quality Specialist required by my client, a Pharmaceutical Manufacturing business based in Kent. You will manage QMS System Owner for all Deviations, CAPAs, Audits, PQRs, ComplaintsCustomer first line quality contact. Attend customer meetings and work with the business to implement customer requirementsTo work with QPs and Development to assist in driving continuous quality improvements.To be considered for the role of Quality Specialist, you will:Demonstrate a good understanding of GMP for IMP and developmentEducated to Science degree or equivalentERP software experience preferable.This is a permanent role, based in Queenborough. Relocation assistance available 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.
      • queenborough, south east
      • permanent
      • £45,000 - £55,000, per year, Relocation Package
      • randstad cpe
      My client, a leading pharmaceutical manufacturer/ CDMO, has a great opportunity for an experienced Regulatory Affairs Specialist to join their team in Kent in Queenborough. As Regulatory Affairs Specialist, you will: License maintenance and variations processes in place and continuously improvedSite registrations processes in place and continuously improvedProduct registrations in compliance with details registered by Marketing Authorisation Holder Management of Regulatory activities to meet legal and company standards consistent with the manufacture of formulated products. Ensure that expert know how exists within the Regulatory Team to ensure that the Regulatory Strategy is clear To be considered for the role of Regulatory Affairs specialist, you will:Educated to degree level in Science Subject or equivalent At least 10 year's experience in a pharmaceutical Regulatory, QMS, QC, QA or Clinical environment Excellent working knowledge of the Finished Dose and the regulatory requirements of the Pharmaceutical industry, including requirements relating to the MHRA, FDA & EMA regulations. A thorough understanding of CGMP requirements is also essential. Significant pharmaceutical compliance and a comprehensive understanding of Regulatory requirements are essentialThis is a permanent position based in Queenborough, Kent. 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, a leading pharmaceutical manufacturer/ CDMO, has a great opportunity for an experienced Regulatory Affairs Specialist to join their team in Kent in Queenborough. As Regulatory Affairs Specialist, you will: License maintenance and variations processes in place and continuously improvedSite registrations processes in place and continuously improvedProduct registrations in compliance with details registered by Marketing Authorisation Holder Management of Regulatory activities to meet legal and company standards consistent with the manufacture of formulated products. Ensure that expert know how exists within the Regulatory Team to ensure that the Regulatory Strategy is clear To be considered for the role of Regulatory Affairs specialist, you will:Educated to degree level in Science Subject or equivalent At least 10 year's experience in a pharmaceutical Regulatory, QMS, QC, QA or Clinical environment Excellent working knowledge of the Finished Dose and the regulatory requirements of the Pharmaceutical industry, including requirements relating to the MHRA, FDA & EMA regulations. A thorough understanding of CGMP requirements is also essential. Significant pharmaceutical compliance and a comprehensive understanding of Regulatory requirements are essentialThis is a permanent position based in Queenborough, Kent. 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.
      • maidenhead, south east
      • temporary
      • £30.00 - £40.00 per hour
      • randstad business support
      JOB TITLE: Quality Assurance & Regulatory Compliance Manager - North EuropeSTART DATE: ASAPEND DATE: 6 Months Contract (Potential Perm)PAY RATE: £30 - £40 Per HourLOCATION: Maidenhead (Office based - Open to flexible) The ClientSpecialising in the emerging market of diagnostics agents , our client is a global health care leader that has a large product area in Diabetes, Arthritis, Sepsis, Pregnancy and many more. The biggest regions that they are working within are in Africa, Asia, Latin America and Eastern Europe. Corona virus has been a massive growth engine for all departments further enhancing portfolios of life-changing technologies. The ProjectWith product development a key component for the team, project management combined with Quality Assurance and Regulatory Compliance is key. The department works closely with their Northern European counterparts on a daily basis to develop new products as well as improving existing products. This involves an ongoing process of establishing and maintaining quality systems within different regional levels. The CandidateThe ideal candidate would be someone who has experience in managing and dealing within multiple projects within a regulated market. They must be able to prioritise tasks to meet the company's milestone with key attention to detail. Furthermore, the ideal candidate must have experience in the implantable medical device industry. However, we would be open to candidates who have experience within the airline industry. What we are looking for:Educated to degree level or with equivalent relevant experienceExperience of medical device regulationsPrevious experience in the implantable medical device industry is preferred.Knowledge of ISO 13485, ISO 9000 and/or ISO 14001 desirable.Analytical, detail oriented. Good organising, planning, verbal and written skills.Strong interpersonal skills, with the ability to build and maintain relationshipsComfortable in a matrix environment and interfacing with different international sites and business units Full Job description will be provided for applicants.Randstad Business Support is acting as an Employment Business in relation to this vacancy.
      JOB TITLE: Quality Assurance & Regulatory Compliance Manager - North EuropeSTART DATE: ASAPEND DATE: 6 Months Contract (Potential Perm)PAY RATE: £30 - £40 Per HourLOCATION: Maidenhead (Office based - Open to flexible) The ClientSpecialising in the emerging market of diagnostics agents , our client is a global health care leader that has a large product area in Diabetes, Arthritis, Sepsis, Pregnancy and many more. The biggest regions that they are working within are in Africa, Asia, Latin America and Eastern Europe. Corona virus has been a massive growth engine for all departments further enhancing portfolios of life-changing technologies. The ProjectWith product development a key component for the team, project management combined with Quality Assurance and Regulatory Compliance is key. The department works closely with their Northern European counterparts on a daily basis to develop new products as well as improving existing products. This involves an ongoing process of establishing and maintaining quality systems within different regional levels. The CandidateThe ideal candidate would be someone who has experience in managing and dealing within multiple projects within a regulated market. They must be able to prioritise tasks to meet the company's milestone with key attention to detail. Furthermore, the ideal candidate must have experience in the implantable medical device industry. However, we would be open to candidates who have experience within the airline industry. What we are looking for:Educated to degree level or with equivalent relevant experienceExperience of medical device regulationsPrevious experience in the implantable medical device industry is preferred.Knowledge of ISO 13485, ISO 9000 and/or ISO 14001 desirable.Analytical, detail oriented. Good organising, planning, verbal and written skills.Strong interpersonal skills, with the ability to build and maintain relationshipsComfortable in a matrix environment and interfacing with different international sites and business units Full Job description will be provided for applicants.Randstad Business Support is acting as an Employment Business in relation to this vacancy.
      • tullamore, international
      • permanent
      • randstad financial services
      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 Profile65+ 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&D. Site Compliance and Product Release Senior Specialist / Qualified PersonThe Site Compliance and Product Release Senior Specialist / Qualified Person will have an active role in batch review and certification for batches manufactured on site as well as partaking in batch review and certification of outsourced manufacturing & testing activities. Duties & ResponsibilitiesSupport the implementation & continuous improvement of an effective quality management system including quality oversight across the site.Assume an active role in the creation, modification and maintenance of the Quality Management Systems supporting operational and release functions.Review & approval of batch records and associated raw data for manufacturing operations to ensure compliance with the requirements of cGMP and batch review and batch disposition process.Participate in and support Site License registration process and future license updates.Review of analytical data and associated reports.Review and approval of non-conformance events and reports including deviations, laboratory investigations & environmental excursions.Perform batch review and approval of investigational products and commercial products.Participate in or lead internal and external audit including 3rd party audits and supplier reviews.Interface with other departments such as Engineering, Laboratories, Operations, Warehouse and Process Development to ensure quality objectives are understood and achieved.Initiate and implement change control activities in accordance with site procedures.Assist with oversight of issue management and non-conformance events to ensure compliance and timely closure.Maintains a contemporary understanding of cGMP regulations and guidance in relation to all aspects of validation across manufacturing, laboratories and facilities.Partake in or lead periodic quality review meetings to ensure compliance and continuous improvement.Write or assist in writing, reviewing and approval of SOPs and other GMP documents. Qualifications and ExperienceBSc, MSC in a relevant discipline (e.g biochemistry, chemistry, process engineering) and be QP qualified.At least 4-7 years relevant experience in a Pharma (Sterile) /BioPharma Manufacturing environment.Biotech/Pharmaceutical QA experience with a strong knowledge of cGMP.Experience of interaction with cross functional departments.Good knowledge of regulatory and cGMP guidelines and directives, including product certification, validation, quality control and manufacture including QbD and Risk Management.Ability to support relevant sections of CTD for regulatory submission.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 Profile65+ 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&D. Site Compliance and Product Release Senior Specialist / Qualified PersonThe Site Compliance and Product Release Senior Specialist / Qualified Person will have an active role in batch review and certification for batches manufactured on site as well as partaking in batch review and certification of outsourced manufacturing & testing activities. Duties & ResponsibilitiesSupport the implementation & continuous improvement of an effective quality management system including quality oversight across the site.Assume an active role in the creation, modification and maintenance of the Quality Management Systems supporting operational and release functions.Review & approval of batch records and associated raw data for manufacturing operations to ensure compliance with the requirements of cGMP and batch review and batch disposition process.Participate in and support Site License registration process and future license updates.Review of analytical data and associated reports.Review and approval of non-conformance events and reports including deviations, laboratory investigations & environmental excursions.Perform batch review and approval of investigational products and commercial products.Participate in or lead internal and external audit including 3rd party audits and supplier reviews.Interface with other departments such as Engineering, Laboratories, Operations, Warehouse and Process Development to ensure quality objectives are understood and achieved.Initiate and implement change control activities in accordance with site procedures.Assist with oversight of issue management and non-conformance events to ensure compliance and timely closure.Maintains a contemporary understanding of cGMP regulations and guidance in relation to all aspects of validation across manufacturing, laboratories and facilities.Partake in or lead periodic quality review meetings to ensure compliance and continuous improvement.Write or assist in writing, reviewing and approval of SOPs and other GMP documents. Qualifications and ExperienceBSc, MSC in a relevant discipline (e.g biochemistry, chemistry, process engineering) and be QP qualified.At least 4-7 years relevant experience in a Pharma (Sterile) /BioPharma Manufacturing environment.Biotech/Pharmaceutical QA experience with a strong knowledge of cGMP.Experience of interaction with cross functional departments.Good knowledge of regulatory and cGMP guidelines and directives, including product certification, validation, quality control and manufacture including QbD and Risk Management.Ability to support relevant sections of CTD for regulatory submission.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
      • chelmsford, east of england
      • temporary
      • £9.50 - £11.81 per hour
      • randstad business support
      Laboratory Analyst Chelmsford£9.50 per hour6 weeks temporary position37 hours per weekAre you interested in science and looking for your next role? Are you pro-active and enjoy working in a close-knit environment? If so, read on.A well known utilities organisation based in Chelmsford are looking for a Laboratory Analyst to join them for 6 weeks on a temporary basis.The Benefits:*Working for an established Water Company*Friendly team*Holiday Pay*Pension schemeThe Duties:* Process samples and/or media in accordance with our documented methods and procedures* Quality compliance* Provide polite efficient service to customers and colleagues* Ongoing competency and CPD* Maintain Health and safety standardsRequirements: Experience working within a laboratory environment - 3 months essentialAble to demonstrate competency in all basic laboratory techniquesMinimum Level 2 i.e.5 GCSEs to include a scientific discipline (with potential to study BTEC or equivalent)Please note, due to the location of this office, you will need to drive and have access to a vehicle.We are looking to get a member of staff in this post as soon as possible, please apply today if this is the role for you.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.
      Laboratory Analyst Chelmsford£9.50 per hour6 weeks temporary position37 hours per weekAre you interested in science and looking for your next role? Are you pro-active and enjoy working in a close-knit environment? If so, read on.A well known utilities organisation based in Chelmsford are looking for a Laboratory Analyst to join them for 6 weeks on a temporary basis.The Benefits:*Working for an established Water Company*Friendly team*Holiday Pay*Pension schemeThe Duties:* Process samples and/or media in accordance with our documented methods and procedures* Quality compliance* Provide polite efficient service to customers and colleagues* Ongoing competency and CPD* Maintain Health and safety standardsRequirements: Experience working within a laboratory environment - 3 months essentialAble to demonstrate competency in all basic laboratory techniquesMinimum Level 2 i.e.5 GCSEs to include a scientific discipline (with potential to study BTEC or equivalent)Please note, due to the location of this office, you will need to drive and have access to a vehicle.We are looking to get a member of staff in this post as soon as possible, please apply today if this is the role for you.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.

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