Senior Quality Assurance Scientist

vor 4 Wochen


Basel, Basel-Stadt, Schweiz Gi Group SA Vollzeit

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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