Senior Quality Assurance Operations Specialist

Vor 4 Tagen


Basel, Basel-Stadt, Schweiz Gi Group SA Vollzeit

We are seeking a highly skilled Senior Quality Assurance Operations Specialist to join our team at Gi Group SA. This role is responsible for ensuring the quality and compliance of our pharmaceutical manufacturing processes.

Key Responsibilities:

  • Implementing and maintaining Quality Management processes, including Review by Exception (RbE) concept during project phases
  • Review and release of purchased materials, internally manufactured materials, buffer/media assemblies, intermediates, and drug substance
  • 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 ensuring its execution within the due date

Quality Focus:

  • Adhering to general cGMP rules, Quality policies, procedures, and instructions as rolled out by the Quality function and endorsed by site management
  • Actively contributing to continuous quality improvement initiatives and deviation reporting and follow-up

EHSS Commitment:

  • Adhering to general safety rules, policies, procedures, and instructions as rolled out by the EHSS functions and endorsed by site management
  • Actively contributing to safety initiatives and issues, as well as near-miss reporting and follow-up

Essential Qualifications:

  • Pharmacist, Chemist/Biologist/Microbiologist/Biochemist/Immunologist with a master's degree or higher
  • 3-5 years of experience in the pharmaceutical industry (biotech company) and not less than 1 year in commercial batch release
  • Knowledge of pharmaceutical manufacturing processes, particularly focusing on biologic drug substance
  • Fluent communication (oral and written) in German and English


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