What are the responsibilities and job description for the Validation Engineer position at Katalyst Healthcares and Life Sciences?
Responsibilities :
- Functional requirement specification, function risk assessment, installation qualification, operational.
- Qualification, performance qualification, traceability matrix, project release notes, system certification summary).
- Execute validation activities in computerized system and ensure 21 CFR part 11 compliance. Knowledge in GAMP.
- Preparing risk assessment for functional requirements and providing testing strategy, implementing technical & procedural controls as part of mitigation.
- Preparing SOP / Work instruction for equipment and software-based systems.
Requirements :
