Quality Assurance Manager

vor 3 Wochen


Basel, Basel-Stadt, Schweiz Gi Group SA Vollzeit
About the Role

Gi Group SA is seeking a Quality Assurance Manager to join their team in Basel, Switzerland. The successful candidate will be responsible for supporting the implementation of Annex 1 requirements in the Clinical Supply Centre for sterile Drug Products (Parenterals) within IMP Switzerland.

Key Responsibilities
  • Represent Quality Assurance while driving all activities related to a successful implementation of Annex 1 within IMP Quality Operations Switzerland
  • Maintain and continuously support all Qualification/Validation and parenteral manufacturing activities within IMP Quality Operation Switzerland
  • Support and collaborate with Quality Assurance Managers within IMP Quality Operations Switzerland
  • Provide sound technical and quality assurance expertise for review and approval of quality related documents
  • Partner with all stakeholders within the Clinical Supply Centre as well as with Technical Development and provide guidance to ensure successful delivery of the Annex 1 implementation goals
Requirements
  • BS/MS/PhD Degree in Engineering, Pharmacy, Biology, Biochemistry, Chemistry, Life Science, Pharmacy or equivalent
  • Min. 2-5 years experience in a GMP regulated environment and with Quality Systems, Quality assurance and OT
  • Experience in Quality Risk Management as well as in performing risk assessments (e.g. FMEA)
  • Experience in Qualification / Validation as well as all activities around parenteral manufacturing
What We Offer

The successful candidate will have the opportunity to work in a dynamic team and contribute to the implementation of Annex 1 requirements in the Clinical Supply Centre for sterile Drug Products (Parenterals) within IMP Switzerland.



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