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Computer System Validation Pharma Senior

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Amaris Consulting

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Location:
Belgium , Wavre

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Category:
IT - Software Development

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

Lead computer system validation for automated/computerized systems ensuring GMP compliance across vaccine manufacturing operations.

Job Responsibility:

  • Author/review/approve validation plans, summary reports, and periodic review reports
  • Review design documentation (TCD, ERES, URS, DQ) and qualification protocols/reports (IQ/OQ/PQ)
  • Manage CSV documentation inventory and review SOPs/templates
  • Execute qualification/validation per established methodology
  • manage CAPA, deviations, change control
  • Represent validation function during internal/external audits
  • Lead multidisciplinary teams through validation lifecycle

Requirements:

  • Master's in Sciences/Biological Engineering (Pharmacist, Bio-Engineer, or equivalent)
  • 7-10 years in computer system validation within pharmaceutical manufacturing
  • cGMP regulations (GAMP, Eudralex Vol 4 Annex 11, 21 CFR Part 11)
  • Validation frameworks (ICH, ASTM E2500, lifecycle approach)
  • SAP and MS Office proficiency
  • Fluent in both French and English is mandatory
  • Investigative mindset with strong questioning skills
  • Ability to influence cross-functional teams
  • Rigorous, systematic approach to validation
  • Clear technical writing and stakeholder management
  • Self-directed with critical thinking capabilities
What we offer:
  • Rapid growth: Amaris has doubled its workforce in Belgium in two years, providing numerous growth opportunities for employees
  • Prestigious projects: Candidates will work with renowned clients in the pharmaceutical, biotechnology, and European institutions sectors on impactful missions
  • International environment: An agile and dynamic structure promotes intrapreneurship and meritocracy, with international exposure at the heart of Europe

Additional Information:

Job Posted:
March 19, 2026

Employment Type:
Fulltime
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