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