Consultant validation systèmes informatisés en life sciences F/H
Core
Lead digital transformation and validation of computerized systems for Life Sciences clients, ensuring compliance with regulations and quality standards.
Role type
Senior Consultant, Computerized System Validation (CSV)
Builds
Validated IT systems and quality documentation for pharma, cosmetic, and medical device clients.
Domain
Life Sciences (Pharma, Cosmetics, Medical Devices) / Regulatory Compliance / IT Quality
Required skills
GxP environment experience, VSI/VSA functions, Data Integrity, Annex 11 knowledge, GAMP5 knowledge, Quality system management, Project leadership, User needs definition, Regulatory compliance strategy, Methodological improvement, Operational maintenance
Preferred skills
None stated
Technologies
None stated
Responsibilities
Pilot projects with project owners, Define user and regulatory needs, Monitor quality systems for IT, Implement IT compliance strategy and conduct validations, Write quality documentation, Propose methodological and technical project improvements, Maintain validated solutions in operational state
Seniority
Mid-Senior, hands-on IC