·      Directed QA oversight of analytical data review for stability programmes covering BCG, SARS-CoV-2, Omicron-JN.1, XBB, ROTA, CyTb, and Erythropoietin products, ensuring GMP compliance and data integrity.

·      Evaluated stability and release data trends to support regulatory submissions, product lifecycle management, and health authority readiness.

·      Led QA walkthroughs across QC laboratories including Microbiology, Chemistry, Virology, and Molecular Biology to strengthen compliance and inspection preparedness.

·      Approved stability protocols, analytical method validation documents, specifications, and controlled formats through EDMS workflows.

·      Supported regulatory inspections, audit responses, and war room activities as QA scribe, ensuring accurate documentation and timely closure of observations.

·      Managed implementation and monitoring of STAR LIMS and contributed to Trackwise CFT workflows for effective quality event management.

·      Reviewed contamination control strategy (CCS) documents, environmental monitoring trends, and quality risk assessments to enhance compliance controls.

·      Investigated deviations, assessed root causes, and verified CAPA effectiveness through quality system reviews.

·      Collaborated with cross-functional teams to drive continuous improvement initiatives within analytical quality operations.