Senior Quality Assurance Specialist in Pharmaceutical Manufacturing
vor 16 Stunden
Job Summary
We are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Gi Group SA. In this role, you will be responsible for ensuring the quality of our pharmaceutical manufacturing processes and products.
About the Role
This is a full-time position that requires a strong background in quality assurance, with a focus on pharmaceutical manufacturing. The ideal candidate will have a deep understanding of cGMP rules, quality policies, procedures, and instructions as rolled out by the Quality function and endorsed by the site management.
Key Responsibilities
- Implementing 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
- Assisting with continuous improvement initiatives related to quality documents and processes
- Supervising the preparation of the Annual Product Review (APQR) and guaranteeing 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
What We Offer
In exchange for your expertise and dedication, we offer a competitive salary range of €70,000 - €90,000 per annum, depending on your qualifications and experience. Additionally, you will have access to a comprehensive benefits package, including health insurance, retirement savings plan, and paid time off.
How to Apply
If you are a motivated and experienced professional looking for a new challenge, please submit your application documents to us. We look forward to hearing from you
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