Kelly Scientific recruits QA Expert - Aseptic area for its biotechnology partner in Switzerland for a permanent position.
As a member of the quality department, your mission is to act as a Quality partner for operational units.
You ensure Systems and documentation, compliance and regulatory GMP requirements.
You act as a QA representative for QA routine tasks and also QA projects.
- Participate to the Quality activities related to the batch record review, product release, and/or raw materials (release, specification implementation, etc.)
- For change control, review and evaluate change requests according to processes, methods, quality systems and applicable regulatory files to meet Corporate, Divisional and Regulatory requirements (incl. IND, BLA, MAA files)
- Provide quality oversight in term of solving problems/root cause for deviation and CAPA
- Be a leader in the implementation of facility projects in conformance with regulatory requirements
- Be involved in preparation and/or presentation during GMP audits
- University Degree in Pharmaceutical Sciences, Biochemistry, Biology, or related scientific field
- Minimum 5-year work experience within biotechnology or pharmaceutical company in QA position or QA projects
- French mother tongue - Fluent in English - minimum B2