29 Oct
|
Alimentiv
|
Quebec City
29 Oct
Alimentiv
Quebec City
Computer system validation specialists apply GxP compliance and testing expertise at Alimentiv, supporting reliable GCP-regulated systems with IT and Quality teams.
As a Computer System Validation Specialist, you will lead validation from planning through execution. The work covers validation documentation, requirements testing, defect management, and change management. You will support compliant solutions across a global CRO focused on gastrointestinal diseases.
Key Responsibilities: Execute computerized system validation under GxP and 21 CFR Part 11
Develop plans, scripts, traceability matrices, and summary reports
Coordinate testing with IT, Quality, stakeholders, and vendors
Track defects, deviations, incidents, resolutions, and closure documentation
Train teams on validation procedures, tools, and documentation standards
Requirements: Bachelor's degree or equivalent education and experience
Three to five years of relevant experience
Experience validating GCP-regulated systems in regulated industries
Understanding of validation, change control, training, and audit readiness
Solid communication and cross-functional collaboration skills
Bring validation documentation, testing coordination, and regulatory knowledge to strengthen system quality and compliance at Alimentiv.
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📌 Computer System Validation Specialist (Quebec City)
🏢 Alimentiv
📍 Quebec City