Srihari Rao
IT-Validation||CSV||GxP||Non GxP||GAMP||QMS||Healthcare/Lifescience||Compliance
- Role
- Consultant at Biocon Biologics
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Srihari Rao
4 years of experience in Pharma IT Application Support & CSV across GxP / Non‑GxP…
Experience
Consultant
May 2025 — Present · Bengaluru, IN
Performed Computer System Validation (CSV) and qualification activities, ensuring compliance with FDA 21 CFR Part 11, EU Annex 11, and GAMP 4 guidelines. • Successfully managed and executed Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols with complete validation documentation, including Requirement Traceability Matrix (RTM). • Actively monitored and maintained over 110+ laboratory instruments, performing periodic reviews, date/time synchronization validations, and managing automated/manual backup and restoration processes according to the scheduled planner. • Provided user account creation and access control for equipment, enabling users to perform tasks in a compliant and secure manner. • Conducted diverse types of software testing including Unit Testing, Sanity Testing, Regression Testing, and User Acceptance Testing (UAT) to support system validation and production releases. • Authored and maintained Standard Operating Procedures (SOPs), validation deliverables, and Quality Management System (QMS) documentation to ensure regulatory compliance and audit readiness. • Supported and managed QMS-related activities, including Change Control, CAPA (Corrective and Preventive Actions), Deviation Management, and Incident Management, contributing to continuous quality improvement initiatives. • Coordinated effectively with vendors for timely issue resolution, ensuring minimal disruption to operations.
Education
Sivanthi Matriculation Higher Secondary School
12th
2016 — 2017
St Joseph Engineering College, Mangaluru
Master of Computer Applications - MCA
2021 — 2022
Mgm college udupi
Bachelor of Computer Application
2017 — 2020
Sivanthi matriculation higher secondary school
Sslc
2014 — 2016
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