IT Systems Validation Specialist

Tasks/Responsibilities

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).

MORE PRECISELY

• Carry out periodic evaluations of the systems to validate them with the applicable regulations
• Assess risks and impacts, anticipate audits and ensure that everything is done in accordance with standards
• Prepare and coordinate the validation phases of IT systems and write the documentation
• Issue strategy recommendations to establish good GxP practices
• Work closely with two compliance specialists
• Participate in the evaluation and qualification of IT suppliers

PROFILE

• 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
• Spirit of mutual aid and interest in the pharmaceutical sector
• Knowledge and ease with IT system an asset
• BAC in computer science or equivalent
• Bilingualism required (French and English)