Senior Quality Assurance Specialist

Vor 4 Tagen


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

We are seeking a Senior Quality Assurance Specialist to join our team in Basel, Switzerland. As a key member of our Quality Operations Unit, you will play a crucial role in ensuring the quality and compliance of our Investigational Medicinal Products (IMPs) manufactured and packed for clinical studies in Switzerland.

Job Summary

The ideal candidate will have sound quality assurance knowledge and experience in the area of Annex 1 implementation, sterile drug product manufacturing, qualification, and validation as well as parenteral manufacturing activities. You will be responsible for supporting and driving the implementation of Annex 1 requirements at the Clinical Supply Centre Basel, maintaining the Right to Operate by ensuring quality and compliance requirements according to Health Authority expectations and Company Standards for IMP products.

Key Responsibilities
  • Support and drive implementation of Annex 1 requirements during implementation in the Clinical Supply Centre for sterile drug product (parenterals) within IMP Switzerland.
  • 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.
Requirements

To be considered for this role, you must have:

  • A BS/MS/PhD degree in Engineering, Pharmacy, Biology, Biochemistry, Chemistry, Life Science, 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 performing risk assessments (e.g. FMEA).
  • Experience in Qualification / Validation as well as all activities around parenteral manufacturing.
What We Offer

In return for your expertise, we offer a competitive salary of €70,000 - €90,000 per year, depending on experience, plus benefits including health insurance, pension plan, and opportunities for professional growth and development.



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