Senior Quality Assurance Scientist
vor 2 Wochen
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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