Quality Assurance Specialist for Biologics Manufacturing

vor 1 Woche


Basel, Basel-Stadt, Schweiz Gi Group SA Vollzeit
About Gi Group SA

We are a leading recruitment agency in the pharmaceutical industry, connecting top talent with exciting job opportunities. Our mission is to provide exceptional staffing solutions that drive business growth and success.

Job Description

Salary: CHF 80,000 - 110,000 per year

Gi Group SA is seeking an experienced Quality Assurance Specialist to join our team in Switzerland. As a key member of our quality team, you will be responsible for ensuring the highest standards of quality in biologics manufacturing.

Key Responsibilities:

  • Implement and maintain quality processes for review/approval of master batch records/executed batch records, including writing of relevant procedures.
  • Review and release of purchased materials, internally manufactured materials, including buffer/media assemblies, intermediates, and drug substance, including writing of relevant procedures.
  • 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.
  • Supervise the preparation of the Annual Product Review (APQR) and guarantee its execution within the due date.

Requirements:

  • Bachelor's degree in a relevant field, such as pharmacy, chemistry, biology, microbiology, or biochemistry.
  • At least 3-5 years of experience in the pharmaceutical industry, preferably in commercial batch release.
  • Knowledge of pharmaceutical manufacturing processes, particularly in biologic drug substance.
  • Fluent communication skills in German and English.
  • Experience in SAP and electronic MES is an asset.

Benefits:

  • Competitive salary and benefits package.


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