IT Systems Validation Expert

4 weeks ago


BasSaintLaurent, Canada DELAN - IT Head Hunters Full time
Job Summary

The IT Systems Validation Specialist will be responsible for ensuring that the IT infrastructure and systems comply with specific industry standards (Health Canada, FDA, GAMP5, and others).

Key Responsibilities:

  • Conduct periodic evaluations of systems to validate them against applicable regulations
  • Assess risks and impacts, anticipate audits, and ensure compliance with standards
  • Prepare and coordinate validation phases of IT systems and write documentation
  • Develop strategy recommendations for establishing good GxP practices
  • Collaborate with compliance specialists
  • Participate in the evaluation and qualification of IT suppliers

Requirements:

  • 5+ years of IT experience
  • Professional experience in systems validation and/or compliance
  • Knowledge of GAMP5 and FDA standards, especially Title 21 CFR Part 11
  • Strong analytical and problem-solving skills
  • Bilingualism (French and English) required


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