Computer System Validation Specialist at Alimentiv validates GCP-regulated systems using quality-focused documentation and testing. Collaborate with IT, Quality, and business teams in a regulated environment.
As a Computer System Validation Specialist, you will lead validation activities from planning through execution. The work covers GxP, 21 CFR Part 11, quality systems, and Software Development Lifecycle processes. You will support compliant, reliable solutions while guiding system quality, integrity, and continuous compliance.
Key Responsibilities:
- Execute computerized system validation activities under GxP requirements
- Develop plans, scripts, matrices, reports, and release documentation
- Coordinate testing with IT, Quality, stakeholders, and vendors
- Manage testing defects, deviations, incidents, and closure documentation
- Guide change management and validation procedures for teams
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
- Strong communication and cross-functional collaboration skills
Apply your validation, testing, documentation, and compliance expertise to support reliable systems at Alimentiv.
Computer System Validation Specialist in Toronto 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.
