At BIOCON LIMITED, I handle Corporate Quality Assurance across SOP governance, internal audits, and supplier quality for APIs, Biosimilars, and Devices facilities. I implemented the supplier qualification module through TrackWise, improving traceability, compliance, and audit readiness.
I manage quality systems, supplier and contract manufacturer quality, and responses to regulatory and customer queries. My experience includes inspections by USFDA, Health Canada, EUGMP, ANVISA, Cofepris, and Russia GMP.
Earlier, at JUBILANT GENERICS LIMITED, I led the IPQA team for pilot and commercial-scale API manufacturing blocks and handled site quality systems. Across roles at CIPLA LIMITED and HIKAL LIMITED, I also worked on API production and quality assurance, including audits, validation, and batch release activities.
