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Senior quality assurance specialist

Next Generation
Quality assurance specialist
Posted: 11 January
Offer description

Senior Quality Assurance SpecialistLocation:DublinContract:Full-time, permanentThe OpportunityWe are partnering with aglobal pharmaceutical organisationto appoint aSenior QA Specialistto support quality operations across international markets. This role sits within a growing quality function and offers broad exposure across commercial, distribution, supplier, and compliance activities at a regional or global level.The successful candidate will play a key role in maintaining and enhancing the Pharmaceutical Quality System, working closely with internal stakeholders and external partners to ensure ongoing cGxP compliance.Key ResponsibilitiesSupport day-to-day Quality Assurance operations across commercial and clinical productsProvide QA oversight for manufacturing, distribution, and pharmacovigilance activitiesProvide Quality oversight of Contract Manufacturing Organisations (CMOs) and third-party suppliersReview and approve product quality investigations and associated CAPAsSupport supplier qualification and maintenance of the Approved Supplier ListCoordinate and support internal and external audits, including follow-up actionsSupport drafting, review, and maintenance of Quality AgreementsCompile Annual Product Quality Reviews (APQRs)Support regulatory inspections, renewals, and responses to compliance queriesContribute to continuous improvement and risk management activitiesBuild effective working relationships with Quality partners across the supply networkCandidate ProfileBachelor's degree in a scientific discipline5-7 plus years in quality assurance in pharmaceutical or biopharma manufacturingStrong working knowledge of GMP and GDP requirementsExperience supporting investigations, deviations, CAPA, and product complaintsExposure to solid oral dosage and/or liquid dosage manufacturing and packagingExperience working with CMOs and external suppliers in a QA capacityRP / DRP experience is a distinct advantageComfortable interpreting regulations and making quality decisions with appropriate governanceThe Next Step for you:Should this position be of interest to you please forward your CV to Sarah Mac Mullan from Next Generation Recruitment or alternatively call on the main line on Next Generation are specialists in Supply Chain, Procurement, Engineering, Quality, Technical and Operation (permanent, contract and temporary) positions.Applications are in strict confidence.Next Generation will never share your data outside of our organisation without your prior written consent.Please read our Data Protection Policy on our website.

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