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Quality Operations Manager

Talentmark
Hertfordshire
Job type
permanent
Location
Hertfordshire, England
Talentmark are recruiting for a Quality Operations Manager, to join a well-established and successful global pharmaceutical company, based in Hatfield, Hertfordshire, on a permanent basis. Role: This role is responsible for Quality Operations and Quality Assurance activities, ensuring GMP compliance and quality system support for the manufacture, packaging, testing, storage, and distribution of marketed drug products. Key duties will include: Ensure quality system procedures and processes meet corporate, regulatory, and industry requirements and promote site adherence to them. Support site compliance activities, including implementation of new GMP requirements and inspection readiness programs. Support and (where required) lead Quality Operations planning and provide QA oversight for QC and Production activities to enable timely batch review, release, and distribution. Perform batch review of site and non-site manufactured batch records, as required. Monitor and report Quality Management System performance metrics and KPIs. Input and lead Quality Management Review meetings (as required.) Represent Quality Operations during regulatory inspections, customer audits, and third-party audits and support internal and external audit programs. Lead the Product Quality Review (PQR) program, including trend analysis and reporting. Author, review, and approve SOPs and other quality documentation such as PQRs, deviations, complaint...

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