Lakshman Yerra

At Vertex Pharmaceuticals, I support computer system validation for manufacturing execution and lab systems in a commercial biologics environment, with a focus on 21 CFR Part 11 and data integrity. I built and maintain traceability matrices for three active system implementations and supported two system go-lives without validation-related delays.

At Agios Pharmaceuticals, I led CSV for LIMS and chromatography data systems supporting QC and R&D labs, from URS through PQ report approval. I also reviewed about 18 validated systems and worked with IT to correct data integrity gaps identified during ALCOA+ reviews.

At Natco Pharma Ltd., I qualified manufacturing and packaging equipment and executed cleaning validation for six multi-product equipment trains. I supported process validation for three oral solid dosage products and WHO GMP and Indian FDA audits, with no critical validation-documentation findings.

I began at Lupin Limited, assisting with qualification protocols before taking on independent protocol writing. Across my roles, I’ve worked on IQ/OQ/PQ, deviations and CAPA, change control, and validation documentation in pharmaceutical and biotech settings.