Senior Quality Assurance Scientist
vor 4 Wochen
We are seeking a highly skilled Senior Quality Assurance Scientist to join our team at Gi Group SA.
The ideal candidate will have a strong background in pharmaceutical manufacturing processes, particularly in biologic drug substance.
Key Responsibilities:
- Implementation of Manufacturing Execution System (MES) with regards to QM processes, including 'Review by Exception RbE' concept.
- Implementation and Maintenance of Quality processes for Review / Approval of master batch records/ executed batch records.
- Review and release of purchased materials, internally manufactured materials including buffer/media assemblies, intermediates and drug substance.
- Review and approval of operational elements such as procedures and related documents including specifications.
- Assist with continuous improvement initiatives related to quality documents and processes.
Requirements:
- Pharmacist, Chemist / Biologist / Microbiologist / Biochemist or Immunolgist with master degree or higher.
- 3-5 years in pharmaceutical industry (biotech company) and not less than 1 year in commercial batch release.
- Fluent communication (oral and written) in German and English.
- Experience in SAP and electronic MES (manufacturing execution system) is an asset.
Please submit your application documents to the designated contact person.
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