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Contract

Quality Officer- Compliance and Process Support

Leicester
money-bag 10000-500000 Annual
3085438650
Posted 3 days ago

Quality Officer - Compliance and Process Support (Quality Assurance) Leicester Sterile Manufacturing 15-month Fixed Term Contract Full time (37 hours/week) Immediate Start Inizio Engage has an exciting opportunity for a Quality Officer - Compliance and Process Support to join our Client''s Quality Assurance team, supporting our Sterile Manufacturing facilities. Reporting to the Principal Quality Officer - Compliance and Process Support, you will act as the primary QA liaison for sterile manufacture of marketed and investigational medicinal products, playing a key role in maintaining regulatory compliance and quality excellence. About the role You will work closely with Sterile Manufacturing to ensure ongoing compliance with GMP, ISO 13485, 21 CFR, Medicines Regulations, and internal procedures. This is a highly visible role with significant interaction across manufacturing, microbiology, clients, and auditors. Key responsibilities include: Managing Quality Systems and GMP compliance within Sterile ManufacturingInvestigation and review of Quality Incidents, Deviations, OOS results, and Customer ComplaintsPerforming regular Gemba walks across manufacturing areasSupporting microbiology investigationsTracking and closing CAPAs and effectiveness checksInstigating, reviewing, and approving Change ControlsPlanning, performing, and closing out internal auditsDelivering and coordinating training sessionsReviewing and updating SOPsQA review of Batch Manufacturing and Packaging ..... full job details .....

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