Ensure GCP systems meet compliance standards at Alimentiv through validation expertise, documentation, and cross-functional collaboration. Work across regulated technology initiatives. As a Computer System Validation Specialist, you will validate computerized systems and software supporting GCP activities. The position covers GxP, 21 CFR Part 11, and regulatory requirements. You will partner with IT, Quality Assurance, business stakeholders, and vendors while supporting compliant project delivery. Your work will strengthen system quality, integrity, and ongoing compliance. Key Responsibilities:
Execute computerized system validation activities under GxP requirements Develop validation plans, test scripts, and traceability matrices Coordinate testing, defect triage, deviations, and incident resolution Facilitate validation documentation review, approval, execution, and closure Guide teams on procedures, change management, and regulatory standards Requirements:
Bachelor's degree and three to five years' relevant experience Experience validating GCP-regulated systems in regulated industries Understanding of validation, documentation, change control, and audit readiness Cross-functional collaboration with stakeholders and external vendors Strong written and verbal communication skills Apply validation, documentation, and compliance expertise to support reliable GCP-regulated systems throughout Alimentiv projects.
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Computer System Validation Specialist GCP in Winnipeg employer: Alimentiv
At Alimentiv, we pride ourselves on being a purpose-driven employer that invests in our people and their professional growth. Our collaborative work culture fosters innovation and accountability, while our comprehensive benefits, including education reimbursement and mentorship programs, ensure that you feel valued and supported in your career journey. Join us in advancing therapies for gastrointestinal diseases and be part of a team that is dedicated to making a meaningful impact in the lives of patients worldwide.
