Computer System Validation Specialist

Function

  • 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

Profile

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

Contact person

M Gharbi