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13 years of experience

Skills

Cleaning & Process Validation Regulatory Compliance Quality Management Systems (QMS) CAPA & Change Control Technology Transfer & Scale‑up Training & Development SAP LIMS e‑VLMS TrackWise QEDGE Caliber (DMS & QAMS) Strategic Business Leadership Problem Solving Team Building

Experience

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.

Languages

English

fluent

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Last updated: 1 month ago