Senior Quality Assurance Specialist
vor 18 Stunden
Gi Group SA is seeking a highly skilled and experienced Senior Quality Assurance Specialist to join our team. In this role, you will be responsible for ensuring that all manufacturing processes are in compliance with Good Manufacturing Practices (GMP) regulations.
Key Responsibilities:- Support and drive the implementation of Annex 1 requirements at the Clinical Supply Centre Basel.
- 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.
- Provide sound technical and quality assurance expertise for review and approval of quality-related documents.
- Partner with stakeholders within the Clinical Supply Centre as well as with Technical Development to ensure successful delivery of the Annex 1 implementation goals.
- 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 in performing risk assessments.
- 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 ability to prioritize, simplify, and connect the dots.
- Proven ability to work independently and in a team towards results.
- A dynamic and challenging work environment.
- The opportunity to work on complex projects and contribute to the success of our company.
- A competitive salary and benefits package.
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