---
title: "Shiva Prasath Purushothaman - Senior Test Engineer in Chennai | Tal"
description: "Meet Shiva Prasath Purushothaman, Senior Validation & QA Engineer | GxP & CSV Specialist | Pharma & Life Sciences Compliance | Oracle Argus, TrackWise, API, SQL Testing | Audit and Quality System based in Chennai."
image: "https://tal.club/meet/shiva-prasath/share-image"
---

# Shiva Prasath Purushothaman on Tal

## Headline

Senior Validation & QA Engineer \| GxP & CSV Specialist \| Pharma & Life Sciences Compliance \| Oracle Argus, TrackWise, API, SQL Testing \| Audit and Quality System

## About

I am a passionate Validation & QA Engineer with 3\+ years of experience in the pharmaceutical and life sciences domain, specializing in GxP\-compliant Computer System Validation \(CSV\) and quality assurance\. I have hands\-on expertise delivering end\-to\-end validation for critical systems, including Oracle Argus \(Pharmacovigilance\), TrackWise \(QMS\), PharmaReady, codeBeamer, QC Veeva Vault, and Apprentice\.IO \(Manufacturing\)\. My skill set covers authoring and executing Validation Plans, Functional Risk Assessments \(FRA\), IQ/OQ/PQ protocols, Requirement Traceability Matrices \(RTM\), and Test Summary Reports \(TSR\)\. I am highly experienced in manual and API testing \(REST & GraphQL\), SQL data validation, and aligning projects with global regulatory standards such as FDA 21 CFR Part 11, GAMP 5, and EU Annex 11\. I also support audit readiness activities, deviation management, and CAPA implementation to ensure compliance and data integrity\. I thrive on working with regulated systems that protect patient safety and product quality\. Passionate about continuous improvement, I enjoy collaborating with cross\-functional teams to deliver audit\-ready, high\-impact solutions\.

## Location

Chennai

## Work experience

Senior Test Engineer at HCL Technologies, Jul 2024 \- Present · 2 yrs, Authored and executed validation deliverables including Validation Plans, Functional Risk Assessments \(FRA\), OQ/PQ protocols, Requirement Traceability Matrices \(RTM\), and Validation Summary Reports \(VSR\)\. Led deviation management, change controls, root cause analysis, and CAPA implementation, ensuring improved compliance and audit readiness\. Supported creation of EMA and US FDA safety reports in Oracle Argus, strengthening global regulatory compliance\. Reviewed and approved URS, FRS, and SRS documents for comprehensive traceability\. Conducted manual and API testing \(REST & GraphQL\), ensuring end\-to\-end system validation\.

Senior Validation Engineer at hcl\-technologies, Jun 2024 \- Present · 2 yrs 1 mo, Chennai, Tamil Nadu, India, • Developed comprehensive validation deliverables including Validation Plans, Test Plans, Functional Risk Assessments \(FRA\), Requirement Traceability Matrices \(RTM\), Test Summary Reports \(TSR\), and Validation Summary Reports \(VSR\)\. • Executed Operational Qualification \(OQ\) and Performance Qualification \(PQ\) protocols in compliance with GAMP 5 and 21 CFR Part 11\. • Led deviations, change controls, impact/risk assessments, root cause analysis, and CAPA implementation\. • Reviewed URS, FRS, and SRS for validation planning and ensured complete traceability\. • Conducted manual testing and API validation for REST and GraphQL endpoints\. • Managed discrepancies and coordinated project documentation and closure\.

Validation trainee at Navitas Life Sciences, Dec 2022 \- Jun 2024 · 1 yr 7 mos, Chennai, Tamil Nadu, India, • Developed and executed test cases, test scripts, and validation protocols in alignment with regulatory standards\. • Prepared key validation deliverables: Validation Plan, Functional Risk Assessment \(FRA\), Test Plan, Requirement Traceability Matrix \(RTM\), Qualification Summary Report, and Validation Summary Report\. • Conducted requirement analysis by studying URS, FRS, and SRS documents for accurate test planning\. • Participated in deviation handling, change control, and risk assessments to ensure system compliance\. • Collaborated with cross\-functional teams to support audits and improve overall system validation quality\.

Validation Specialist at Navitas Life Sciences, Dec 2022 \- May 2024 · 1 yr 6 mos, Executed process and cleaning validation protocols, supporting successful regulatory inspections for top pharma clients\. Prepared and reviewed validation documentation including Validation Plans, Qualification Summary Reports, and Traceability Matrices\. Collaborated in deviation handling, risk assessments, and periodic review activities, ensuring lifecycle compliance\. Validated and maintained QMS in TrackWise, improving documentation control and audit trail integrity\. Actively participated in internal and external audits, contributing to smooth inspection outcomes\.

## Education

B\.E mechanical, Mechanical Engineering, Jeppiaar Engineering College

High School Diploma, ARR Matriculation Higher Secondary School

[View the original profile](https://tal.club/meet/shiva-prasath)

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