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      • 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
      • tullamore, international
      • permanent
      • randstad financial services
      Position Title : Process ScientistDepartment : Development and ManufacturingLocation : Tullamore Role PurposeThe role of this key team member within the Development/Production Department will include responsibility for the development and validation of processes for recombinant proteins for veterinary use. This will include working with teams, both in their Tullamore site and externally with Contract Manufacturing Organisations for some of the process development activity, and technical transfer of the process into the client's facility in Tullamore. Duties & ResponsibilitiesHave significant knowledge of bioprocessing.Applies technical skills and functional knowledge independently and proactively. May act as a technical resource within their own group/team.Assist with decisions that impact your own work/ team group with the ability to make- decisions that may resolve moderately complex problems.Exercises judgement utilising established approaches as well as prior work experience, consulting others appropriately.Works under limited supervision and provides novel process solutions, new ideas and knowledge. Contributes to achievement of goals at the team level and takes responsibility for a portion of the team's milestones or deliverables. Proactively offers to investigate a problem using its own resources to resolve an issue.May provide training/ coaching/ mentoring within the work group/ team and supervise other colleagues.Influences at the work group and/or project team level.Modifies existing processes to improve the efficiency of the work group or function.To support the development, optimisation, scale-up and validation of all steps in the monoclonal antibody production process.Work with external service providers (CMOs) to provide the necessary technical support for successful completion of projects, including the transfer of the process into the site facility.Support the writing of Batch Manufacturing Records, SOPs, and other quality system documentation required for GMP manufacture.Provide hands-on technical support for all manufacturing activities, including buffer/media preparation, cell culture and purification processes.Provide technical input and support writing of technical reports required for regulatory purposes.Participate in Quality and Safety regulatory audits.Identify continuous improvement initiatives and action plans to implement operational excellence and lean practices.POSITION SPECIFICATIONQualifications, Experience, Skills, Knowledge and AttributesBSc, MSc, PhD in a relevant discipline (e.g. biochemistry, chemistry, process engineering) or equivalent experience.2-5 years' relevant experience in bioprocess development and/or manufacturingProtein purification, lab-scale and pilot scale.Knowledge of UNICORN programming is desirable.Lean six sigma certified. Skills with chromatography systems, filtration systems.Working in a controlled regulated environment e.g. GMP/GLP.Knowledge of analytical methods required for protein characterisation.Knowledge of key suppliers of process materials and equipment, including disposable systems.Experience working with external contractors.Excellent project management capability.Excellent verbal and written communication skills. Ability to maintain very clear records of work completed.Ability to work effectively as part of a team across all departments in their Tullamore site. 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
      Position Title : Process ScientistDepartment : Development and ManufacturingLocation : Tullamore Role PurposeThe role of this key team member within the Development/Production Department will include responsibility for the development and validation of processes for recombinant proteins for veterinary use. This will include working with teams, both in their Tullamore site and externally with Contract Manufacturing Organisations for some of the process development activity, and technical transfer of the process into the client's facility in Tullamore. Duties & ResponsibilitiesHave significant knowledge of bioprocessing.Applies technical skills and functional knowledge independently and proactively. May act as a technical resource within their own group/team.Assist with decisions that impact your own work/ team group with the ability to make- decisions that may resolve moderately complex problems.Exercises judgement utilising established approaches as well as prior work experience, consulting others appropriately.Works under limited supervision and provides novel process solutions, new ideas and knowledge. Contributes to achievement of goals at the team level and takes responsibility for a portion of the team's milestones or deliverables. Proactively offers to investigate a problem using its own resources to resolve an issue.May provide training/ coaching/ mentoring within the work group/ team and supervise other colleagues.Influences at the work group and/or project team level.Modifies existing processes to improve the efficiency of the work group or function.To support the development, optimisation, scale-up and validation of all steps in the monoclonal antibody production process.Work with external service providers (CMOs) to provide the necessary technical support for successful completion of projects, including the transfer of the process into the site facility.Support the writing of Batch Manufacturing Records, SOPs, and other quality system documentation required for GMP manufacture.Provide hands-on technical support for all manufacturing activities, including buffer/media preparation, cell culture and purification processes.Provide technical input and support writing of technical reports required for regulatory purposes.Participate in Quality and Safety regulatory audits.Identify continuous improvement initiatives and action plans to implement operational excellence and lean practices.POSITION SPECIFICATIONQualifications, Experience, Skills, Knowledge and AttributesBSc, MSc, PhD in a relevant discipline (e.g. biochemistry, chemistry, process engineering) or equivalent experience.2-5 years' relevant experience in bioprocess development and/or manufacturingProtein purification, lab-scale and pilot scale.Knowledge of UNICORN programming is desirable.Lean six sigma certified. Skills with chromatography systems, filtration systems.Working in a controlled regulated environment e.g. GMP/GLP.Knowledge of analytical methods required for protein characterisation.Knowledge of key suppliers of process materials and equipment, including disposable systems.Experience working with external contractors.Excellent project management capability.Excellent verbal and written communication skills. Ability to maintain very clear records of work completed.Ability to work effectively as part of a team across all departments in their Tullamore site. 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
      • 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 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&D.Responsibilities:* provide analytical competence and technology to Tullamore Site organisation so that all analytical methods are state-of-the-art and in compliance with regulatory expectations* to coordinate and control the day to day operations of the Quality Control laboratory including but not limited to providing a safe, secure and efficient working environment* ensuring all QC equipment is safely operated* all physical QC resources are maintained* stored and organised to allow efficient and effective operation* to control and direct all QC resources* operations and facilities in order to test all site materials from Raw Materials through to API* stability and utility samples and to manage and direct a QC team of skilled based individuals through sound personnel practices such as: - Performance management- Relevant and effective inductions- Identification of training needs- Coaching and Discipline* responsible for developing* monitoring* implementing, and reporting on the operating budget and staffing plan;- to monitor and report quality control progress- notifying any predicted shortfall or discrepancies against timescale and budgets.* immediate notification to the Site Quality Leader of any Quality Control issues and provide accurate and relevant information as required by the business* partner with the Quality Operations Lead to ensure alignment with planning and scheduling requirements, operational needs and implementation of OPEX and Drive continuous improvement initiatives which positively impact cycle time, productivity, efficiency and quality of work through Lean methodology* partner with QSS and Compliance Lead in support of implementation of Quality Systems and Inspection Readiness including internal and Health Authority Inspection* direct and oversee analytical services performed at Tullamore Site and third-party contract laboratories* oversee and direct the analytical method transfer for Tullamore Site products* ensure that analytical methods are adequately developed, validated, transferred and maintained* approve CMC documents related to analytical methods development & validations* develop and implement analytical method validation plans* ensure that adequate and timely analytical support for investigations (e.g. deviations, complaints) and troubleshooting is provided, where needed in conjunction with GMT, Opex, external 3rd party laboratories, and other involved functions to minimise the impact on product availability and sales* to continuously review quality control processes, procedures and capabilities in order to sustain the most cost-effective and efficient methods for meeting quality requirements* ensure the adequate and timely qualification of contract laboratories using appropriate quality management tools to monitor and ensure third party lab compliance with Quality Policies and applicable regulatory requirements on an ongoing basis e.g. QA Agreements, audits with appropriate follow up, risk assessments, Product Optimisation action plans, performance indicators, follow up stability and product quality review* actively manage the Quality Control Analytical team and set up their development and objective targets. They will mentor their team providing input and coaching on behaviors and professional development will provide timely feedback; and evaluate performance of direct reports after obtaining the relevant functional input and evaluation* review and monitor action plans for correction of audit observations related to the Analytical Labs and follow-up as appropriate.Education:* Bachelor of Science in Chemistry with +15 years of quality control and analytical laboratory experience and proven demonstrated experience in leading a QC team* Minimum of 5 years PROGRESSIVE experience in the quality control, quality assurance, manufacturing function of veterinary or human API products with prior roles at Manager Level in a Quality/Technical Manufacturing environment an essential prerequisite* Recognised Lean Six Sigma Qualification (Green Belt or Black belt)* Training & Experience at the application of Change Execution Methodology. 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 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.Responsibilities:* provide analytical competence and technology to Tullamore Site organisation so that all analytical methods are state-of-the-art and in compliance with regulatory expectations* to coordinate and control the day to day operations of the Quality Control laboratory including but not limited to providing a safe, secure and efficient working environment* ensuring all QC equipment is safely operated* all physical QC resources are maintained* stored and organised to allow efficient and effective operation* to control and direct all QC resources* operations and facilities in order to test all site materials from Raw Materials through to API* stability and utility samples and to manage and direct a QC team of skilled based individuals through sound personnel practices such as: - Performance management- Relevant and effective inductions- Identification of training needs- Coaching and Discipline* responsible for developing* monitoring* implementing, and reporting on the operating budget and staffing plan;- to monitor and report quality control progress- notifying any predicted shortfall or discrepancies against timescale and budgets.* immediate notification to the Site Quality Leader of any Quality Control issues and provide accurate and relevant information as required by the business* partner with the Quality Operations Lead to ensure alignment with planning and scheduling requirements, operational needs and implementation of OPEX and Drive continuous improvement initiatives which positively impact cycle time, productivity, efficiency and quality of work through Lean methodology* partner with QSS and Compliance Lead in support of implementation of Quality Systems and Inspection Readiness including internal and Health Authority Inspection* direct and oversee analytical services performed at Tullamore Site and third-party contract laboratories* oversee and direct the analytical method transfer for Tullamore Site products* ensure that analytical methods are adequately developed, validated, transferred and maintained* approve CMC documents related to analytical methods development & validations* develop and implement analytical method validation plans* ensure that adequate and timely analytical support for investigations (e.g. deviations, complaints) and troubleshooting is provided, where needed in conjunction with GMT, Opex, external 3rd party laboratories, and other involved functions to minimise the impact on product availability and sales* to continuously review quality control processes, procedures and capabilities in order to sustain the most cost-effective and efficient methods for meeting quality requirements* ensure the adequate and timely qualification of contract laboratories using appropriate quality management tools to monitor and ensure third party lab compliance with Quality Policies and applicable regulatory requirements on an ongoing basis e.g. QA Agreements, audits with appropriate follow up, risk assessments, Product Optimisation action plans, performance indicators, follow up stability and product quality review* actively manage the Quality Control Analytical team and set up their development and objective targets. They will mentor their team providing input and coaching on behaviors and professional development will provide timely feedback; and evaluate performance of direct reports after obtaining the relevant functional input and evaluation* review and monitor action plans for correction of audit observations related to the Analytical Labs and follow-up as appropriate.Education:* Bachelor of Science in Chemistry with +15 years of quality control and analytical laboratory experience and proven demonstrated experience in leading a QC team* Minimum of 5 years PROGRESSIVE experience in the quality control, quality assurance, manufacturing function of veterinary or human API products with prior roles at Manager Level in a Quality/Technical Manufacturing environment an essential prerequisite* Recognised Lean Six Sigma Qualification (Green Belt or Black belt)* Training & Experience at the application of Change Execution Methodology. 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

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