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مهارتها
تجربه
Deputy Manager – Compliance (Drug Product)
Biocon Biologics Ltd., Bengaluru
2023-07 -
Defined strategic approaches and prepared global SOPs for cleaning validation, including cleaning verification matrices, soil selection, and cross‑contamination study protocols. Established acceptance criteria for cleaning effectiveness, residual limits, and microbial control, and selected appropriate manual and automated cleaning methods. Managed the Cleaning Verification (Changeover) program and provided training to Production, QA, QC, Microbiology, and Engineering teams. Oversaw CAPA processes, conducted internal audits, and ensured ongoing regulatory compliance, leading to successful FDA and other regulatory inspections with zero observations.
زبانها
English
fluent
آخرین بهروزرسانی: 2 ماه پیش