Full-time
Specialist - Computer System Validation
Posted by Jubilant Pharma, LLC • Montreal, Montreal (administrative region), Canada
About the Role
JOB DESCRIPTION
At Jubilant Radiopharma , we’re advancing healthcare through innovation in radiopharmaceuticals. As a Specialist in CSV, IT & Data Governance , you’ll play a critical role in ensuring our digital systems meet the highest standards of regulatory compliance, data integrity, and operational excellence. This is your opportunity to be a trusted SME, lead cross‑functional initiatives, and directly influence regulatory readiness across our IT landscape.
What You’ll Do
Lead CSV & Data Governance Strategy
- Own and execute the site-level Computer System Validation (CSV) Master Plan .
- Develop and maintain robust policies and SOPs aligned with:
- FDA 21 CFR Part 11
- Health Canada GUI‑001
- EU Annex 11
- GAMP5 , PIC/S , and other global regulatory frameworks.
- Champion data integrity and governa...
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