Deputy Manager (QA) November 2022 - Present
As the Deputy Manager (QA) at Biocon Biologics Ltd., I oversee critical responsibilities, including managing Out of Specification (OOS) and Out of Limit (OOL) investigations, reviewing and approving microbiology protocols, reports, risk assessments, technical documents, and specifications. Additionally, I lead the review and approval process for microbiology testing parameters results for drug products, water systems, stability, and environmental monitoring. Ensuring laboratory compliance with regulations, handling audits, and focusing on sterility assurance for the aseptic processing area are integral parts of my role, contributing to maintaining the highest standards of product quality and safety.