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Audit senior lead (emea gmp audit)

Parma
Experteer Italy
Audit
Pubblicato il Pubblicato 8h fa
Descrizione

Ph3Experteer Overview /h3pIn this Audit Senior Lead role within GSK’s Quality organization, you will lead GMP and Compliance audits of Biopharm, Vaccines and Pharmaceutical facilities across the Global Supply Chain. You’ll assess adherence to GMP, policies and regulatory commitments, covering internal and external sites, LOCs, RD and LSPs, and provide sterile manufacturing SME input to the EMEA auditing team. The role emphasizes clear reporting of risks and action plans to senior management, with significant cross-site interaction. A key hook is contributing to quality and regulatory excellence across a global network while enabling continuous improvement. /ph3Retribuzione / Benefits /h3ulliManage complex stakeholder engagement across the audit network (Site Directors, Site Quality Directors, VPs/Heads of support functions, and RD Quality) /liliAudit Global Supply Chain sites, LOCs, external manufacturers, RD sites, LSPs, and facilities serving EMEA and other regulated markets /liliConduct unannounced audits and for-cause audits based on regulatory actions or identified risks /liliPerform process, quality system-specific, and targeted audits /liliAudit against risk mitigation plans or regulatory citation commitments /liliProduce clear, concise audit reports for senior management and ensure corrective actions are implemented /li /ulh3Responsabilità /h3ulliDegree in a relevant Scientific, Technical or Engineering discipline /liliRelevant and specific experience in Steriles/Biopharm/Vaccines/Pharmaceutical industries /liliSubject matter expertise in worldwide cGMPs, regulatory requirements, and Quality Management Systems for sterile/pharma manufacturing and packing /liliExperience identifying and managing complex Quality and Compliance risks and issues /li /ul /p #J-18808-Ljbffr

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