Senior Quality Assurance Scientist

Vor 3 Tagen


Basel, Basel-Stadt, Schweiz Gi Group SA Vollzeit

About Gi Group SA

We are a leading recruitment agency in the pharmaceutical industry, and we are seeking an experienced Senior Quality Assurance Scientist to join our client's team.

Job Description:

The Senior Quality Assurance Scientist will be responsible for ensuring that all quality processes and procedures are followed and implemented within the manufacturing environment. This includes reviewing and approving master batch records, executed batch records, and purchasing materials.

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
  • Supervision of the preparation of the Annual Product Review (APQR) and guarantees its execution within the due date

Requirements:

  • Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, Microbiology, Biochemistry, or Immunology
  • 3-5 years of experience in the pharmaceutical industry, preferably in commercial batch release
  • Knowledge of pharmaceutical manufacturing processes with particular focus on biologic drug substance
  • Fluent communication (oral and written) in English
  • Experience in SAP and electronic MES is an asset

Estimated Salary: The estimated salary for this position is around $85,000 - $110,000 per year, depending on qualifications and experience.



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