Expert Assurance Qualité Qualification (F/H/X)
Core
Ensuring compliance with GMP and site Quality Assurance rules for the qualification of Computerized Systems within the pharmaceutical manufacturing environment.
Role type
Senior Quality Assurance Expert (Computerized Systems Qualification)
Domain
Pharmaceutical manufacturing / Computerized System Validation (CSV)
Required skills
GMP compliance, Computerized System Validation, deviation management, CAPA management, audit preparation, regulatory inspection support, technical solution proposal
Preferred skills
Engineering school background in Quality Assurance or System Validation, matrixed environment experience, proactive collaboration
Technologies
GMP documentation systems, Computerized System Validation tools
Responsibilities
Organize and perform QA verification of raw data and review/approve GMP documents related to qualification activities; Decide and provide recommendations in accordance with GMP requirements; Pilot deviations, investigations, CAPAs, and changes related to qualification tracking; Review and approve qualification strategies and follow-up for Computerized Systems; Maintain the qualified status of Computerized Systems; Actively participate in the preparation, execution, and follow-up of Group audits, regulatory inspections, and self-inspections in the qualification domain.
Seniority
Senior, hands-on IC