GCP Computer System Validation Specialist at Alimentiv supports compliant computerized systems through validation planning, testing, and documentation. Work with cross-functional teams on regulated solutions. This specialist role focuses on GCP-regulated software and computerized systems within Alimentiv’s clinical research setting.

You will apply GxP, 21 CFR Part 11, quality system principles, and validation standards. Your work will help project teams document requirements, manage testing outcomes, and maintain compliance.

Key Responsibilities

- Define validation strategies with internal and external partners
- Ensure requirements are tested and documented appropriately
- Facilitate documentation review, approval, execution, and management
- Track defect resolution, deviations, incidents,



and validation closure
- Train teams on tools, standards, procedures, and best practices Requirements:
- Degree in computer science, technology, engineering, or related field
- Three to five years of relevant experience or equivalent
- GCP validation experience in pharmaceutical or regulated industries
- Knowledge of quality systems and regulatory requirements
- Experience with Software Development Lifecycle processes Bring GCP validation, regulatory documentation, and testing expertise to Alimentiv’s compliant technology initiatives.

📌 GCP Computer System Validation Specialist (Toronto)
🏢 Alimentiv
📍 Toronto