Quality Assurance Process Specialist
On-siteToulouse, Occitanie, France
Job Summary
Manage daily production operations and cell bank management in accordance with company rules and regulatory requirements including GMP Part II, Annex 2, and ICH Q9/Q10. Support quality assurance tasks by handling CAPAs, change controls, and non-conformities assigned to you. Conduct walkdowns in controlled atmosphere areas and review, approve, and generate batch records, logbooks, protocols, and reports. Prepare for and participate in regulatory audits and inspections across Europe and the United States. Implement Sandoz procedures, contribute to service improvement projects, and serve as a backup for QA colleagues in other sectors. This role works within a dynamic team supporting the Just-Evotec Biologics acquisition and operates under extended hours based on service constraints.
Required Qualifications
- bac+5 with a specialization in quality assurance in the pharmaceutical field
- at least 3 years of successful operational experience
- solid knowledge of GMP Part II
- solid knowledge of GMP Annex 2
- solid knowledge of ICH Q9/Q10
- bilingual in French and English
- ability to work on extended hours
- GMP Part II
- GMP Annex 2
- ICH Q9/Q10
Desired Qualifications
- Experience in the field of bioproduction
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