Jaya Kumar Email & Phone Number

Bangaluru

• Preparation and review of Quality documents Technical offer, DQ, Pre-FAT, FAT, SAT- IQ and OQ as per regulatory norms.• System Validation based on ASME BPE, PLC Validation based on 21 CFR Part 11 and Risk Assessment (GAMP 5).• Performing Pre-FAT(Factory Acceptance Test) Activity- Preparation and Review of Component Literature and corresponding certificates. Onsite Verification of Design Documents  GA (General Assembly) - System, Vessel, Control Panel. P&ID.… Show more • Preparation and review of Quality documents Technical offer, DQ, Pre-FAT, FAT, SAT- IQ and OQ as per regulatory norms.• System Validation based on ASME BPE, PLC Validation based on 21 CFR Part 11 and Risk Assessment (GAMP 5).• Performing Pre-FAT(Factory Acceptance Test) Activity- Preparation and Review of Component Literature and corresponding certificates. Onsite Verification of Design Documents  GA (General Assembly) - System, Vessel, Control Panel. P&ID. BOM (Bill of Material)-Mechanical, Electrical and Instrumentation & Automation. Electrical and Pneumatic Schematics onsite verification. Confirming Calibration of Instrumentation Components.• Performing FAT Activity (Factory Acceptance Test) – Performing the same activities as Pre- FAT and interacting with Clients. Show less

Hyderabad Area, India

• Conduct the validation Activities like Process Equipments, Clean Utilities and Black Utilities.• Preparation of Quality documents URS, DQ, FAT, SAT, IQ, OQ and PQ as per regulatory norms.• System Validation, PLC Validation based on GAMP 5, 21 CFR Part 11.• Preparation and Execution of QAP (Quality Assurance Plan) based on risk assessment approach to perform retrospective qualification of Process Equipments and Utility Systems.• Execution of Qualification documents and progress… Show more • Conduct the validation Activities like Process Equipments, Clean Utilities and Black Utilities.• Preparation of Quality documents URS, DQ, FAT, SAT, IQ, OQ and PQ as per regulatory norms.• System Validation, PLC Validation based on GAMP 5, 21 CFR Part 11.• Preparation and Execution of QAP (Quality Assurance Plan) based on risk assessment approach to perform retrospective qualification of Process Equipments and Utility Systems.• Execution of Qualification documents and progress towards closure. • Compile relevant documentation from contractors, suppliers, and other departments for inclusion in reports.• Participate in cross-functional teams as required.• Co-ordinate qualification activities with engineering, construction and commissioning activities.• Co-ordinate qualification activities with contractors and vendors as required. Show less

Jalandhar Area, India

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M.Tech, Biotechnology, 7.94/10

B.Tech, Biotechnology, 74.8%