About
Most people in Computer System Validation come from IT or QA. I came from a genetics lab bench — and that scientist's instinct for risk is what I bring to every validation project. For nearly 5 years, I've worked across the US and Europe helping pharmaceutical, biotech, and clinical research organizations validate the digital systems that regulators — and patients — depend on. That includes systems for clinical data capture, laboratory operations, quality management, and regulatory reporting. What I do: → Risk-based validation (GAMP 5, CSA) — so systems get validated fast without cutting corners on compliance → Regulatory audit readiness (FDA 21 CFR Part 11, EU Annex 11, GxP/cGMP) — across both GxP and non-GxP systems → Full validation lifecycle ownership — URS, risk assessments, IQ/OQ/PQ, Validation Plans, CAPA, periodic reviews, system retirement Where I've done it: Currently a CSV Risk Consultant at EY, working across Quality, IT, R&D, and business teams to keep global pharma systems compliant and audit-ready. Before that, nearly 4 years at Zifo as a Validation Analyst and later Senior Validation Analyst, validating clinical, laboratory, and quality systems — including applications used to collect and manage clinical trial data. The science behind the compliance: MSc in Biomedical Genetics (VIT, Vellore), BSc in Microbiology & Biochemistry (St. Xavier's, Mumbai), plus research experience in cancer cytogenetics and HIV/AIDS research. That background means I don't just check boxes — I understand why the science matters, which shapes how I assess risk. I post here about validation, compliance, and life at the intersection of science and regulated tech. Always glad to connect with people in pharma, biotech, QA, or compliance — or to swap notes on risk-based validation and CSV best practices.
Work experience
Risk Consultant at EY, Mar 2025 - Present · 1 yr 5 mos, Bengaluru, Karnataka, India, CSV Risk Consultant enabling compliant, risk-based validation of GxP and non-GxP systems for global pharmaceutical organizations. Passionate about driving quality as per GAMP 5, FDA 21 CFR Part 11, EU Annex 11 regulation. Also assisting in periodic reviews, change management and cross-functional collaboration across Quality, IT, R&D, and business teams.
Senior Validation Analyst at Zifo, Mar 2024 - Mar 2025 · 1 yr 1 mo, Chennai, Tamil Nadu, India
Validation Analyst at Zifo, Aug 2022 - Apr 2024 · 1 yr 9 mos, Chennai, Tamil Nadu, India
Associate Analyst at Zifo, Aug 2021 - Aug 2022 · 1 yr 1 mo, Chennai, Tamil Nadu, India
Team Assistant at NcodeX, Aug 2021 - Dec 2022 · 1 yr 5 mos
Research Volunteer at NcodeX, Aug 2021 - Dec 2022 · 1 yr 5 mos
Dissertation Trainee at Advanced Centre for Treatment, Research and Education in Cancer(ACTREC), Dec 2020 - May 2021 · 6 mos, Mumbai, Maharashtra, India, Cancer Cytogenetics Department
Summer Research Fellow at HIV AIDS laboratory,JNCASR, Bengaluru, May 2019 - Jul 2019 · 3 mos, Bengaluru
