Quality Assurance Manager
vor 13 Stunden
We are seeking a highly skilled QA Manager to join our team at Gi Group SA. As a QA Manager, you will be responsible for ensuring the quality and compliance of our pharmaceutical products.
Key Responsibilities:- Support and drive the implementation of Annex 1 requirements 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.
- 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.
- Support your area of responsibility at HA inspections and internal audits.
- BS/MS/PhD Degree in Engineering, Pharmacy, Biology, Biochemistry, Chemistry, Life Science, Pharmacy or equivalent.
- Min. 25 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 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.
- Experience with Annex 1 is a plus.
- Experience in Discrepancy Management, CAPA, Technical Change Management is a plus.
- Project management skills is a plus.
- Proficient contribution to health authority inspections and internal GMP audits is a plus.
- Fluent in German, English B2.
- 100% workload.
- Start date: as soon as possible.
- End date: 1 year.
- Extension: very likely.
- Work location: Basel.
- Remote work: only by exceptions.
Please apply online for this exciting opportunity. For further information about the position, please contact your Gi Group Recruiter, Fatbardha Igrishta.
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