Senior Quality Assurance Scientist

vor 4 Wochen


Basel, Basel-Stadt, Schweiz Gi Group SA Vollzeit
Job Description

We are seeking a highly skilled Senior Quality Assurance Scientist to join our team at Gi Group SA. As a key member of our quality assurance team, you will be responsible for ensuring the highest standards of quality in our pharmaceutical manufacturing processes.

Key Responsibilities:

  • Implementation of Manufacturing Execution System (MES) with regards to QM processes, including 'Review by Exception RbE' concept during the project phase
  • Implementation and Maintenance of 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
  • Supervision of the preparation of the Annual Product Review (APQR) and guarantees its execution within the due date

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

About Us:

Gi Group SA is a leading provider of staffing and recruitment services in the pharmaceutical industry. We are committed to delivering high-quality solutions to our clients and candidates.



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