Madhan Kumar
computer system validation specialist
- Role
- Senior Consultant at Infosys
- Location
- Coimbatore, TN, IN
- LinkedIn followers
- 500 followers
About Madhan Kumar
Experience in drafting SOP\'s, Validation Master Plans (VMP), Installation Qualifications (IQ),Operational Qualification (OQ), Performance Qualification (PQ), 21 CFR Part 11 Assessment and ValidationSummary Reports (VSR). Experience in developing and reviewing User Requirement Specifications (URS), Functional Requirement Specifications (FRS) and Design Specifications (DS) in compliance and conformance with FDA. Prepared Validation Master Plan (VMP) for validating analytical laboratory equipment\'s. Responsible for validation & strategizing CSV activities for instrument/ Equipment/ software being installed in Quality control department. Responsible for prioritizing, executing, coordinating, and maintaining validation related activities for GxP Computer Systems in accordance with governing regulations/ guidelines and defined company quality standards, procedures, and policies. performing GXP assessment Responsible for End-to-end validation of pharma equipment and software applications being installed in the quality control department. Hands on experience in JIRA and QASE tools for creating test cases for OQ\'s and PQ\'s. Responsible for Testing and Validation for SaMD Projects on GAMP guidelines. Handling of Change Control, Non-conformances (Incidences, OOS & OOT). Familiarity with Agile Methodology and V model. Analyzed the validation impact of changes through risk assessment.
Experience
Senior Consultant
Jun 2025 — Present · Coimbatore, IN
Education
Sri Ramakrishna mission vidyalaya college of arts and science
Master of Science
2015 — 2017
PSG College of Arts and Science
Bachelor's degree
2012 — 2015
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.