Ingénieur(e) Assurance Qualité Opérationnelle- H/F
On-siteParis, Île-de-France, France
Job Summary
Manage and process deviations, investigations, OOS/OOT, and CAPAs in collaboration with operational teams. Approve quality documents including procedures, batch records, work instructions, change control, and associated quality documentation. Ensure equipment and computerized systems are qualified and validated according to CSV regulations, GMP, and site quality procedures. Participate in batch record reviews (RDL) to guarantee compliance prior to quality release. Contribute to continuous improvement projects enhancing quality performance, documentation robustness, and gap reduction. Accompany project teams during qualification, validation, and change management activities to maintain validated installation status. Analyze quality impacts related to equipment, process, and computerized system evolutions. Conduct internal audits, inspections, and site verifications to maintain GMP/BPF regulatory compliance.
Required Qualifications
- Diplômé(e) d'une formation Bac+5 en pharmacie, qualité, biotechnologies, génie des procédés, chimie ou équivalent
- 5 à 8 ans minimum en Assurance Qualité Opérationnelle au sein d'un environnement pharmaceutique ou biotechnologique
- bonne connaissance des référentiels GMP/BPF
- connaissance des processus qualité
- connaissance des exigences réglementaires applicables à l'industrie pharmaceutique
- expérience sur la gestion des déviations
- expérience sur la CAPA
- expérience sur le change control
- expérience sur les revues documentaires
- Anglais professionnel apprécié
Desired Qualifications
- connaissances en qualification/validation
- connaissance de la réglementation CSV (GAMP 5, Annexe 11, Data Integrity, 21 CFR Part 11)
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