Senior Quality Assurance Scientist

vor 2 Wochen


Basel, Basel-Stadt, Schweiz Gi Group SA Vollzeit

Job Summary


We are seeking a highly skilled Sr Scientist QA Operation to join our team at Gi Group SA. This is a unique opportunity to work in the pharmaceutical industry, specifically in biologic drug substance manufacturing.


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.
  • 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 pharmaceutical industry solutions. We are committed to delivering high-quality products and services to our clients.


How to Apply


Please send your full application documents to zahra.safari@gigroup.ch.


Job Details



  • Branche: Pharma-Industrie
  • Funktion: Qualitätsprüfung
  • Führungsperson: Nein
  • Anstellungsart: Festanstellung


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