Expert Compliance et Validation de Systèmes Informatisés F/H
Core
Expert in Computerized System Validation (CSV) and Compliance for a veterinary pharmaceutical site, ensuring regulatory adherence and data integrity.
Role type
Senior IC Compliance and Validation Expert (CSV)
Builds
Validated computerized systems and data integrity controls for veterinary drug production
Domain
Pharmaceutical / Veterinary Health / GxP
Required skills
GAMP5, 21 CFR Part 11, Data Integrity, Excel, Project Management
Preferred skills
Regulatory strategy, Audit preparation, Change management, System retirement/archiving
Technologies
Excel, Computerized Systems
Responsibilities
Define CSV standards and validation strategies, support technical experts in validation lifecycle, participate in audits and investigations, manage document control and change management, perform routine maintenance and periodic reviews.
Seniority
Senior, hands-on IC