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- Capture defects and report following the defect management process.
- Prepare deviations/CAPAs based on audit findings
- Understand user and functional requirements documents thoroughly.
- Perform dry run and report defects if any.
- Incorporate test script errors/review comments, send OQ scripts for pre-approval and execute the approved scripts.
- Perform peer review
- Take ownership of all validation tasks and work with minimal supervision.
- Preparation of Validation Plan, System assessment, 21CRFPart11 assessment and Validation Summary report.
- Author OQ and PQ test scripts based on functional requirement specification.
- Flexible to travel to client location and perform validation activities based on the requirement.
- Coordinate with validation team and track requirement clarifications.
- Provide support to external and internal audits related to system validation activities
- Great interpersonal and communication skills
- Good time-management skills
- 6 years life sciences R&D experience in testing and validation domain
- Bachelor’s Degree
- Critical thinker, Team player and problem-solving skills
Vacancy Type: Full Time
Job Location: Toronto, CA
Application Deadline: N/A