Consultant en Assurance Qualité Réglementaire (Industrie Pharmaceutique) F/H
Core
Pilot the Change Control process for a pharmaceutical manufacturing site, covering initiation, screening, impact assessment, risk assessment, regulatory assessment, action planning, approval, and implementation.
Role type
Senior Regulatory Quality Consultant (Pharmaceutical Manufacturing)
Builds
Change Control processes for pharmaceutical manufacturing sites
Domain
Pharmaceutical industry / Regulatory Quality
Required skills
Change Control process management, Regulatory Quality Assurance, Pharmaceutical manufacturing knowledge, Risk assessment, Impact assessment, Action planning, Client relationship management, Field operations experience
Preferred skills
Engineering school degree, Master 2 or higher in Quality, Pharmacist license, Agile methodology, Adaptability in growing environments
Technologies
Change Control tools
Responsibilities
Lead Change Control process steps (initiation, screening, classification, impact/risk/regulatory assessment, action planning, approval, implementation), Conduct field missions in pharmaceutical production environments, Manage client relationships
Seniority
Senior, hands-on IC
