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1 job found in Tullamore, International

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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

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