Quality Assurance Operations Specialist

vor 3 Stunden


Basel, Basel-Stadt, Schweiz Gi Group SA Vollzeit
Company Overview

Gi Group SA is a leading provider of recruitment and HR services. Our team is dedicated to helping businesses find the best talent in the industry.

Job Description

We are seeking a highly skilled Sr Scientist QA Operation to join our team. As a Sr Scientist QA Operation, you will be responsible for implementing quality processes and ensuring compliance with regulatory requirements.

Responsibilities
  1. Implement Manufacturing Execution System (MES) with regards to QM processes, including 'Review by Exception RbE' concept.
  2. Develop and maintain Quality processes for Review / Approval of master batch records/ executed batch records.
  3. Review and release of purchased materials, internally manufactured materials including buffer/media assemblies, intermediates and drug substance.
  4. Review and approval of operational elements such as procedures and related documents including specifications.
  5. Assist with continuous improvement initiatives related to quality documents and processes.
Requirements

To be successful in this role, you will need:

  • A degree in Pharmacist, Chemist / Biologist / Microbiologist / Biochemist or Immunolgist with master degree or higher.
  • 3-5 years of experience in the pharmaceutical industry, with at least 1 year of experience in commercial batch release.
  • Knowledge of pharmaceutical manufacturing processes, particularly biologic drug substance.
  • Fluent communication skills in German and English.
  • Experience in SAP and electronic MES is an asset.


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