Ranadheer K

Supported Computer System Validation (CSV) activities for medical device manufacturing and distribution systems within FDA-regulated environments. • Executed validation lifecycle activities for GxP computerized systems including warehouse systems, labeling applications, quality systems, and temperature monitoring applications. • Performed system impact assessments, Part 11 evaluations, risk assessments, and validation planning activities in compliance with FDA and GAMP 5 standards. • Developed and executed IQ/OQ/PQ protocols, validation test scripts, traceability matrices, and validation summary reports for computerized systems. • Supported change control assessments, software upgrades, periodic reviews, and revalidation activities for validated applications. • Collaborated with QA, IT, Engineering, Manufacturing, and Operations teams to support compliance and validation timelines. • Assisted with audit readiness activities by maintaining accurate and inspection-ready validation documentation within EDMS platforms. • Participated in SOP development and updates related to CSV procedures, data integrity, and validation processes. • Served as Computer System Validation (CSV) Subject Matter Expert during audits and regulatory inspections.

Executed equipment qualification and process validation activities for sterile pharmaceutical manufacturing operations. • Generated and executed IQ/OQ/PQ protocols for autoclaves, VHP chambers, refrigerators, freezers, and controlled temperature equipment. • Supported cleaning validation initiatives and validation lifecycle documentation activities. • Performed temperature mapping and heat distribution studies using Kaye validation systems and electronic data loggers. • Conducted risk assessments, deviation investigations, and CAPA activities to maintain regulatory compliance. • Supported audit readiness, change control assessments, and requalification activities for validated systems.