Senior Quality Assurance Operations Specialist
Vor 5 Tagen
We are seeking a highly skilled Senior Quality Assurance Operations Specialist to join our team. In this role, you will be responsible for implementing and maintaining quality processes in biopharmaceutical manufacturing.
About the RoleThis is a key position within our organization that requires a strong background in pharmaceutical manufacturing processes, particularly in biologic drug substance production. You will work closely with cross-functional teams to ensure adherence to cGMP guidelines, develop and implement new processes, and improve existing ones.
Main 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.
- 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.
- Knowledge of pharmaceutical manufacturing processes with particular focus on biologic drug substance.
- Fluent communication (oral and written) in German and English.
- Experience in SAP and electronic MES (manufacturing execution system) is an asset.
Gi Group SA is a leading provider of recruitment services in the pharmaceutical industry. We offer a range of solutions to help our clients find the best talent for their organizations.
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