Senior Biopharmaceutical Quality Assurance Specialist

Vor 7 Tagen


Basel, Basel-Stadt, Schweiz Gi Group SA Vollzeit
About Gi Group SA

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 Description

We 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.
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.
  • 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.
Compensation and Benefits

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 Position

This 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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