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
- 2+ 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
- BAC in computer science or equivalent
- French required, functional English on the documentation side (verbal being a strong asset)
