Spécialiste principal(e), validation des systèmes informatisés – Qualité / Senior Specialist, Quality Computer Validation (contrat 18 mois)
Core
Lead or support computer system validation and qualification activities across the system lifecycle for GxP computerized systems, software, and equipment in a regulated pharmaceutical environment.
Role type
Senior Specialist, Quality Computer Validation (IC)
Builds
Validated computerized systems, software, and equipment ensuring compliance with GxP and regulatory requirements.
Domain
Pharmaceutical / Life Sciences / Computer System Validation (CSV)
Required skills
Computer System Validation (CSV), GxP compliance, Risk Assessment, Change Control, CAPA management, IQ/OQ/PQ documentation, SAP ERP, Regulatory inspections
Preferred skills
Controlled-temperature environment validation, Health Canada GMP requirements, French-English bilingualism
Technologies
SAP, GAMP 5, EU Annex 11
Responsibilities
Lead or support computer system validation and qualification activities across the system lifecycle; Author, review and execute validation deliverables including plans, requirements, risk assessments, and test protocols; Prepare and execute installation, operational and performance qualification documentation; Assess change controls, deviations, investigations and CAPA; Coordinate validation activities with cross-functional project teams and external consultants; Improve validation procedures and provide mentorship to colleagues.
Seniority
Senior, hands-on IC