Validation Specialist IS (GxP) -CDI- F/M
Hybrid · Toulouse, Occitanie, France
Job Summary
IS Validation & Compliance in R&D Pharma: Validate and maintain GxP information systems (on-premise and cloud-based) to be compliant, including cloud environments (AWS/Azure); develop and apply risk-based validation strategies, IQ/OQ/PQ, scripted/automated validation, and ensure audit readiness. Role involves system lifecycle management (implementation, upgrades, cloud evolutions), validation of cloud and SaaS solutions, supplier assessments, and cross-functional collaboration with IS, QA, and external vendors. The position supports RUN and CHANGE activities and requires strong knowledge of GAMP 5, 21 CFR Part 11, Annex 11, and cloud governance within a shared responsibility model. Teleworking up to 2 days a week is allowed.
Required Qualifications
- Master’s degree in IT, Quality, Life Sciences, or equivalent
- Minimum 5 years’ experience in IS validation / CSV in a GxP-regulated environment
- Demonstrated experience with cloud system validation and maintenance of validated state
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