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

Hard Skills

• 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

Soft Skills

• Autonomie
• 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

• Français
• Anglais