Parikshith B. J.

Background

About Parikshith B. J.

Parikshith with 7+ years of experience in the field of CSV, IT Quality and Compliance. He has a good understanding of CSV flow, system life cycle, 21CFR Part 11 regulations, Annex 11 and GAMP-5 guidelines and has worked with multiple Pharmaceutical Industry and has completed project as a CSV Consultant. Partnered with Vender, QC, QA and IT for completion of validation activity like installation, qualification, upgradation, SOP’s preparation and release of system and software. He has a good knowledge and hand-on experience on validation of Cloud based application, Spreadsheet, Laboratory equipment’s, PLC, storage device’s, Biometric system, Server client system and ERP system in Pharma domain. He has good knowledge cloud service models like private, public and community cloud, IaaS, PaaS and SaaS. He has worked on various aspects of GxP applications such as Gap Assessment, Risk Assessment, 21 CFR Part 11 Assessment, Business Impact analysis, Vendor Risk Management, Periodic Reviews, Data Migration and Document Management. He has worked on Quality Management Systems on server, workstations, network components, cloud infra and has significant expertise in Computer System Validation to ensure the validated state of the system. Working Knowledge of USFDA, MHRA, WHO regulations with respect to ICH Q8, Q9 and Q10 and has back hand supported client in their audits. Well versed on Change Management and Change Control Procedures, Deviation Handling, and CAPA management.