Harsh Pipalia

Background

About Harsh Pipalia

I am a Validation Analyst with hands-on experience in Computer System Validation (CSV), Quality Assurance, and regulatory compliance with standards like 21 CFR Part 11, EU Annex 11, and GAMP guidelines. I specialize in drafting and executing qualification scripts, including IQ, OQ, PQ, IOPQ, and OPQ, and designing traceability matrices for complex user requirements. At Zifo RnD Solutions, I’ve worked on multiple agile projects, performing dry runs, ad hoc testing, and validation activities for industry-leading systems such as Benchling ELN, Thermo Fisher Watson LIMS, and Sapio LIMS. My focus is on ensuring system efficiency, compliance, and seamless integration while collaborating with cross-functional teams in fast-paced environments. With a B.Tech in Biotechnology (GPA: 8.72) from VIT, I bring strong analytical and problem-solving skills to every task. My internships at Intas Pharmaceuticals and Sumul Dairy strengthened my understanding of GMP, GLP, and quality control, further shaping my ability to excel in regulated environments. Passionate about continuous learning, I adapt quickly to new tools and processes, enabling me to take on both quality-focused and technical roles with confidence. I aim to contribute to innovative projects that advance the pharmaceutical and biotech industries. Let’s connect to collaborate on opportunities in CSV, quality systems, and pharmaceutical IT solutions.