Senior Biopharmaceutical Quality Assurance Specialist
Vor 7 Tagen
Gi Group SA is a leading international staffing company with a presence in multiple countries. We offer a wide range of services, including temporary and permanent recruitment, as well as HR solutions.
Job DescriptionWe are seeking an experienced Senior Biopharmaceutical Quality Assurance Specialist to join our team. As a Senior Biopharmaceutical Quality Assurance Specialist, you will be responsible for ensuring the quality of our products and processes.
Key Responsibilities:- Implement Manufacturing Execution System (MES) with regards to QM processes, including 'Review by Exception RbE' concept during the project phase.
- Implement and maintain Quality processes for Review / Approval of master batch records/ executed batch records including writing of relevant procedures during the project phase.
- Review and release of purchased materials, internally manufactured materials including buffer/media assemblies, intermediates and drug substance including writing of relevant procedures during the project phase.
- 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.
The estimated annual salary for this position is €80,000 - €110,000 depending on experience. Gi Group SA offers a comprehensive benefits package, including health insurance, retirement plan, and paid time off.
About the PositionThis is a full-time position. The successful candidate will be working in a dynamic team environment and will have the opportunity to contribute to the growth and success of our company.
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Basel, Basel-Stadt, Schweiz Gi Group SA VollzeitJob SummaryWe are seeking a seasoned Senior Biopharmaceutical Quality Assurance Specialist to join our team at Gi Group SA. This exciting opportunity will involve implementing and maintaining quality processes, ensuring adherence to cGMP rules, and contributing to continuous improvement initiatives.
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