Sterile Products Quality Assurance Specialist

vor 1 Tag


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

We are seeking an experienced Sterile Products Quality Assurance Specialist to join our team in Basel, Switzerland. The successful candidate will be responsible for supporting the implementation of Annex 1 requirements at our Clinical Supply Centre.

As a member of our Quality Assurance team, you will collaborate with cross-functional teams to ensure the delivery of high-quality sterile drug products that meet regulatory requirements.

The ideal candidate will have a strong understanding of GMP regulations, quality systems, and risk management principles. You will also have experience in qualification/validation and parenteral manufacturing activities.

Responsibilities
  • Support the implementation of Annex 1 requirements at our Clinical Supply Centre
  • Represent Quality Assurance during all activities related to the implementation of Annex 1
  • Maintain and support Qualification/Validation and parenteral manufacturing activities
  • Collaborate with Quality Assurance Managers within the IMP Quality Operations team
  • Provide technical expertise for review and approval of quality-related documents
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
  • At least 2-5 years of experience in a GMP-regulated environment and quality systems
  • Experience in Quality Risk Management and performing risk assessments (e.g., FMEA)
  • Knowledge of Annex 1 requirements and sterile drug product manufacturing
About the Opportunity

This is a full-time position with a salary range of approximately €60,000 - €80,000 per year, depending on experience. Our company offers a competitive benefits package, including health insurance, retirement plan, and paid time off.



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