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Quality Assurance Computer System Validation (CSV)
Katalyst Healthcares & Life Sciences • West Point, Pennsylvania, United States
About the Role
Roles & Responsibilities:
- Responsible for providing quality assurance support and oversight for System Development Life Cycle (SDLC) deliverables of primarily Laboratory Instrument Systems and secondary for Application Systems support GxP operations
- Collaborate with cross-functional team to define risk-based approaches for computer system validation activities and testing.
- Lead validation teams to a better understanding of validation best practices and applying quality principles.
Reviews various GxP deliverables for conformance with SDLC baseline criteria and other internal and external regulations. - Identifies and resolves issues interfering with execution of deliverables.
Enforces Good Documentation Practices and ensures that SDLC deliverables are properly cataloged and available for internal and external regulatory inspection.
Provide additional support with SDLC deliverable...
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