Computer System Validation Specialist
- Execute qualification activities and produce deliverables on Changes and Projects
- Identify in alignment with IT Compliance Lead, the qualification approach and deliverable list.
- Escalate issues/blocking points to the coppany's IT Compliance Lead.
- Write Risk Assessment, Qualification Plan, Report, test protocols, Traceability Matrix
- Write and execute IQ test scripts, support creation and review of OQ and PQ,
- Coordinate test execution in collaboration with IT System Owner, Process/Data Owner and testing team
- Monitor specification creation, test execution and defect management.
- Provide KPI and share validation status with project team
- Direct report to the IT Compliance Lead
- CGMP and specific regulations and guidelines applicable to computerized and automated systems (GAMP, Eudralex Vol 4 annex 11, 21 CFR part 11, …)
- Validation practices and guidelines (life cycle approach, ICH, ASTM E2500, …)
- Technical knowledge of automated and computerized systems
- Critical mind
- Esprit equip
- Leadership skills
- Education, Methodology & Certification Requirements
- Bachelor or Master degree in automation, engineering, IT, sciences or equivalent by experience
- ICT Skills (software, operating systems, hardware, etc.)
- Office 365
Language Proficiency Requirements