Chargé Assurance Qualité des Opérations - H/F (CDI)
On-siteStrasbourg, Grand Est, France
Job Summary
Review and approve Master Batch Records, stability protocols, and qualification documentation within defined timelines. Manage quality events, deviations, and change controls while tracking CAPA actions and compliance indicators. Represent the quality assurance function in client meetings, project calls, and internal/external audits. Evaluate batch dossiers for conformity and quality to facilitate lot release and Certificate of Compliance generation. Conduct line clearance checks and contribute to continuous process improvement initiatives. Full-time day shift with on-call rotation required. BAC+5 in science (Chemistry/Pharma) with five years of industry experience and mandatory English proficiency.
Required Qualifications
- BAC+5 dans le domaine scientifique idéalement Chimie / Pharma
- 5 ans d'expérience dans une fonction similaire
- en industrie pharmaceutique
- Maîtrise des référentiels EuGMP et ICHQ7
- Maîtrise de l'anglais indispensable
Desired Qualifications
- la connaissance d'autres référentiels (diagnostiques, cosmétiques...)
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