---
title: "Shivi Kulshreshtha - IT Analyst in India | Tal"
description: "Meet Shivi Kulshreshtha, IT Analyst at TCS | CSV/ CSA Lead | Computer System Validation | Computer Software Assurance | GxP | FDA 21 CFR Part 11 | HIPAA | GAMP 5 | Pharma/Life Sciences | Compliance | 5+ Years | Open to Opportunities based in India."
image: "https://tal.club/meet/shivi-1/share-image"
---

# Shivi Kulshreshtha on Tal

## Headline

IT Analyst at TCS \| CSV/ CSA Lead \| Computer System Validation \| Computer Software Assurance \| GxP \| FDA 21 CFR Part 11 \| HIPAA \| GAMP 5 \| Pharma/Life Sciences \| Compliance \| 5\+ Years \| Open to Opportunities

## About

I am a Computer System Validation \(CSV\)/ Computer Software Assurance \(CSA\) Lead with 5\+ years of experience driving validation and compliance initiatives for GxP\-regulated computerized systems within the Pharmaceutical and Life Sciences industry\. My expertise lies in delivering inspection\-ready systems by implementing risk\-based validation strategies aligned with FDA 21 CFR Part 11, GxP Regulations, HIPAA, GAMP 5, Data Integrity \(ALCOA\+\) and SDLC best practices\. I have successfully led validation activities across multiple regulated applications, majorly in Manufacturing domain, ensuring regulatory compliance while enabling efficient system releases\. Currently, I lead end\-to\-end system validation, collaborating closely with QA, IT, business stakeholders and vendors to deliver compliant, high\-quality outcomes\. What I Bring: ✔ End\-to\-end Computer System Validation leadership ✔ Risk\-based validation & CSA approach ✔ Change Control, CAPA & deviation management ✔ Strong stakeholder collaboration across global teams ✔ Team mentoring, resource planning & process improvement initiatives I am passionate about strengthening quality culture, data integrity and digital compliance within regulated environments while continuously improving validation efficiency and delivery timelines\.

## Location

India

## Work experience

IT Analyst at Tata Consultancy Services, Jan 2020 \- Present · 6 yrs 7 mos, Noida, · Led CSV activities for 10\+ GxP\-regulated systems for global pharmaceutical client\. · Authored Validation Plan & Reports; Reviewed URS, Risk Assessments, IQ/OQ/PQ protocols, RTM, Test Executions and SOPs while ensuring compliance with FDA 21 CFR Part 11, HIPAA, GAMP 5 and data integrity requirements using risk\-based validation approaches\. · Collaborated with QA, IT, Business SMEs and vendors to ensure successful system implementation and validation\. · Supported internal and external audits, ensuring documentation completeness and inspection readiness\. · Managed Change Controls, CAPAs and Periodic Reviews using ServiceNow\. · Led and mentored a team of 10 validation professionals, improving delivery timelines, compliance and quality\. · Conducted gap analysis and continuous improvement initiatives enhancing validation efficiency\.

System Engineer at Tata Consultancy Services, Jan 2022 \- Jan 2024 · 2 yrs 1 mo, Noida, Uttar Pradesh, India

Associate System Engineer at Tata Consultancy Services, Jan 2021 \- Jan 2022 · 1 yr 1 mo, Noida, Uttar Pradesh, India

Structural Design Engineer\- Trainee at BUILDSWORTH SOLUTIONS PVT LTD, Jul 2019 \- Dec 2019 · 6 mos, Noida, Uttar Pradesh, India, • Designed RCC and steel structures including foot\-over bridges, high\-rise buildings, and water tanks\. • Created BOQs, DBRs, fabrication drawings, and maintained document control and data integrity\.

Summer Trainee at Lower Division, Agra Canal, Jul 2017 \- Aug 2017 · 2 mos, Agra, Uttar Pradesh, India, Studied working of Canal System at Keetham lake in detail\.

Summer Trainee at PUBLIC WORKS DEPARTMENT, AGRA, Jun 2017 \- Jul 2017 · 2 mos, Agra, Uttar Pradesh, India, Studied construction of Cement Concrete Roads in detail\.

## Education

B\.Tech, Civil Engineering, Dr\. A\.P\.J\. Abdul Kalam Technical University, Lucknow

Higher Secondary Certificate, Physics, Chemistry and Maths with English and Physical Education, St\. Marks Public School, V\.P\.O\. Bhagupur, Agra

[View the original profile](https://tal.club/meet/shivi-1)

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