Vishnu Tv

Experience

1. Executive

   Biocon

   Oct 2023 — Present · Bengaluru, IN

   Responsible to ensure Equipment qualification including Green filed and Brown field projects satisfies the applicable procedures of quality management system and the applicable regulations / guidelines like ASTM E2500, ASME SEC DIV I, ISPE C&Q, USFDA, EU GMP, 21 CFR 1, GAMP 5 and ICH• Responsible for the preparation and review of Vendor evaluation, GxP Assessment, System Risk Assessment (SRA), System impact assessment (SIA) Traceability matrix (RTM) and Data integrity assessment (DIA),• Have hand on experience in preparation, review and execution of URS, DQ, PID, FAT, SAT, IQ, OQ and PQ protocol and reports.• Responsible for preparation review and execution of Computer system validation (CSV) IQ/OQ test scripts as per System architecture.• Responsible to ensure all the mitigation related activities from risk assessment are completed before system release.• Prepare and review the document as per the documentation approval matrix focusing on the GxP compliance aspects of system and its operation.• Responsible for the Periodic Performance Validation of clean rooms and clean zone equipment.• Responsible for review of Temperature mapping reports.• Have Knowledge in WHO Supplement 8, ISPE Cold chain management and IS01•••41• Responsible for QMS events such as Change control, Deviation, Investigation, Root cause analysis and CAPA management.

Education

• Govt.polytechnic college chelakkara,kerala

  Mechanical Engineering

• Malabar College Of Engineering & Technology

  Bachelor of Technology - BTech

  2017 — 2021