Consultant validation systèmes informatisés en life sciences F/H
Core
Consultant leading digital transformation and validation of computerized systems for Life Sciences clients, ensuring regulatory compliance and quality.
Role type
Senior IC validation consultant (Life Sciences)
Builds
Validated computerized systems (VSI/VSA) and quality documentation for pharma, cosmetic, and medical device clients.
Domain
Life Sciences (Pharma, Cosmetics, Medical Devices) + Regulatory Compliance (GxP)
Required skills
GxP environment experience, VSI/VSA functions, Data Integrity, Quality IT, Annex 11 knowledge, GAMP5 knowledge
Preferred skills
Project management, stakeholder management, English language skills
Technologies
GAMP5, Annex 11, VSI/VSA tools
Responsibilities
Pilot projects with clients, define user and regulatory needs, follow quality systems for IT, implement compliance strategies, write quality documentation, propose methodological improvements, maintain validated solutions.
Seniority
Mid-level (average 6 years experience)