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- Developed documentation for Equipment/Computer System Validation and System Development Life Cycle (SDLC), encompassing: Risk Assessments - Design Specifications - Validation Plans - User Requirement Specifications - Functional Specifications - Impact Assessments - User Acceptance Testing (UAT)
- Test Scripts - System Test Protocols (IQ/OQ/PQ)
- Traceability Matrix - Summary Reports- Supported qualification activities for controlled temperature units (CTUs), including Refrigerators - Freezers - Incubators - Walk-in environmental rooms - Warehouses
- Reviewed and addressed system-related deviations, non-conformances, and process/product change control, ensuring thoroughness and assessing the impact on quality systems in accordance with FDA, CFR, GxP, and ISO standards.
- Led the implementation of Kneat Gx Validation software and knowledgeable in Windows 7 to 10 upgrade.
- Possess practical application expertise in GxP systems, including Kneat Validation.
- Must be available immediately.
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