Sudiip Bhandari
Medical Devices | URS/FRS | Risk Assessment | V-Model | IQ/OQ/PQ | Report Generation
- Role
- Csv Engineer at Trids Validation Corp
- Location
- El Cerrito, CA, US
- LinkedIn followers
- 500 followers
Experience
Csv Engineer
Jan 2017 — Present · CA, US
Good understanding of System Development Life Cycle (SDLC), GAMP V principles.2. Good understanding in planning and execution of Validation deliverables requirements (URS/ FRS), Risk Assessment(RA), Executing protocols - Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ), creating Requirements Traceability Matrix (RTM), and writing Validation Summary Report (VSR)3. Knowledge on documenting all phases of system life cycle as required by Part11 regulatory requirement.4. Knowledge on GxP including GDP, GMP and GAMP.5. Working in Team and as well as individual contribution during Validation Deliverables.
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