Chargé Assurance Qualité Opérationnelle / Produit – Événements Qualité - H/F - CDI
Core
Managing and piloting quality events impacting products, including deviations, Out-of-Specification (OOS) results, and customer complaints within a pharmaceutical manufacturing environment.
Role type
Operational/Production Quality Assurance Specialist
Builds
Quality management systems and corrective actions for pharmaceutical products
Domain
Pharmaceutical manufacturing (dermo-cosmetics)
Deliverable
client delivery
Required skills
Root cause analysis (5 Whys, 5M, QQOQCCP), CAPA definition and validation, TrackWise data management, BPF knowledge, process knowledge (dry, liquid, paste forms), impact assessment, report writing
Preferred skills
Experience with liquid/paste/dry form manufacturing processes, experience with OOS and customer complaints
Technologies
TrackWise
Responsibilities
Investigate quality events and deviations, define and validate CAPA, approve and close quality events, support field teams in error prevention, write quality documents and investigation reports
Seniority
Mid-level, hands-on IC