Ingénieur / Chargé de Validation informatique F/H
Core
Lead the validation of computerized systems and data integrity for a medical device manufacturing site, ensuring compliance with regulatory standards and managing a team of two.
Role type
Senior Quality Assurance Manager (Computerized System Validation)
Builds
Validated computerized systems and data integrity frameworks for medical device production
Domain
Medical device manufacturing / Quality Assurance
Required skills
Computerized System Validation (CSV) strategy, Risk analysis, Regulatory knowledge (Medical Devices/Pharma), Team management, Data Integrity management, URS development, Quality documentation
Preferred skills
Experience with automated production equipment, Project management
Technologies
GxP, 21 CFR Part 11, ISO 13485, Risk Assessment tools
Responsibilities
Propose and implement CSV strategy, Lead multidisciplinary risk analysis meetings, Develop and maintain validation plans/protocols/reports, Manage validation schedule and KPIs, Participate in User Requirements Specification (URS) writing, Foster CSV culture through training, Manage a team of 2 validators, Ensure Data Integrity compliance and culture
Seniority
Senior, hands-on IC with management responsibilities