Senior QA Operations Specialist

Vor 3 Tagen


Basel, Basel-Stadt, Schweiz Gi Group SA Vollzeit
Job Description

We are seeking a highly skilled Senior QA Operations Specialist to join our team at Gi Group SA.

About the Role

This is a key position responsible for ensuring the quality of our products and services. The successful candidate will be working closely with our manufacturing teams to implement Quality Management (QM) processes, including the Review by Exception concept. Additionally, you will be responsible for reviewing and approving operational elements such as procedures and related documents, as well as supervising the preparation of the Annual Product Review (APQR).

Key Responsibilities

• Implement QM processes, including MES, during project phases
• Maintain Quality processes for review/approval of master batch records/executed batch records
• Review and release purchased materials, internally manufactured materials, and buffer/media assemblies
• Supervise APQR preparation and execution
• Adhere to cGMP rules, Quality policies, and EHSS functions

Requirements

We are looking for candidates with a strong background in pharmaceutical manufacturing processes, particularly biologic drug substance. A Master's degree or higher in a relevant field is required, as well as 3-5 years of experience in the pharmaceutical industry and not less than 1 year in commercial batch release. Fluency in German and English is essential, with experience in SAP and electronic MES being an asset.

Benefits

We offer a competitive salary of around CHF 90,000 per year, based on location and experience. Additionally, you will have access to training and development opportunities, as well as a comprehensive benefits package.

Location

The role is based in [location], Switzerland. If you are a motivated and detail-oriented individual with a passion for quality assurance, we encourage you to apply.

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