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LEAD - TEST VALIDATION
LEAD - TEST VALIDATION
Job Overview
Location
Mississauga, Ontario
Job Type
Full Time Job
Job ID
56337
Date Posted
2 years ago
Recruiter
Raymond Catherine
Job Views
452
Job Description
- Development of validation and testing strategies based on system risk, complexity, and other applicable factors as per the defined procedures
- Authoring/development of validation & testing documentations such as Validation/ Test Plans, Risk Management Plans, Validation/ Test Summary Reports
- FDA 21CFR part 11 regulations knowledge
- Thorough understanding of GAMP5 V-model and risk-based validation process
- Perform Functional Risk Assessment (FRA) on requirements as per defined procedures
- Responsible for validation documentation reviews and overall quality of validation deliverables
- Responsible for Delivery Efficiency and Effectiveness from validation testing point of view
- Manage Change Controls of GxP systems and provide guidance/support to the system owners/ project stakeholders to ensure adherence to internal change control processes
Job ID: 56337
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