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Quality Assurance Manager (f/m/d)

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Zusammenfassung

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Job Details

Ihre Aufgaben

  • GMP-compliant batch record review and approval of batch documentation as well as timely batch evaluation for externally manufactured products within the responsibility of Vaccine External Supplier Quality (ESQA)
  • Preparation and approval of documents for batch release by the responsible institutes/authorities
  • Management of deviations and changes as well as management and tracking of CAPA measures and other QMS documents for external products
  • Daily collaboration and communication with external partners ensuring the professional representation of the company
  • Support in coordinating complaint handling with external partners as well as with global and local functions
  • Support in the preparation of inspections by regulatory authorities, as well as internal inspections and global audits at external partners
  • Coordination of documents required by the regulatory department for registration purposes
  • Coordination of Quality Agreements (QAGs)
  • Support in the creation of global quality metrics/KPIs for external partners

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