Senior Quality Assurance Specialist

Vor 7 Tagen


Basel, Basel-Stadt, Schweiz Gi Group SA Vollzeit

Gi Group SA is a leading staffing and recruitment agency in the pharmaceutical industry. The company is currently seeking a Senior Quality Assurance Specialist to join their team in Basel, Switzerland.

Job Summary

Job Title: Senior Quality Assurance Specialist

Job Type: Temporary/Contract

Location: Basel, Switzerland

Salary: €80,000 - €100,000 per year

About the Role

The successful candidate will be responsible for supporting the implementation of Annex 1 requirements at the Clinical Supply Centre in Basel. This includes maintaining and continuously supporting all Qualification/Validation and parenteral manufacturing activities within IMP Quality Operation Switzerland.

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.
  • Responsible to represent Quality Assurance while driving all activities related to a successful implementation of Annex 1 within IMP Quality Operations Switzerland
  • Maintaining and continuously supporting 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 (e.g. SOPs, qualification, validation 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

To be successful in this role, you will need:

  • 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
  • Fast learner, strong team-player with a high level of self-motivation and with ability to prioritize, simplify and connect the dots.
  • Proven ability to work independently and in a team towards results
  • Excellent planning and organizing skills in order to manage multiple tasks at the same time as well as analytical capabilities and an innovative manner of solving problems
About Gi Group SA

Gi Group SA is a leading staffing and recruitment agency in the pharmaceutical industry. They specialize in providing temporary and contract staff to companies across Europe.



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