Cleaning validation, process validation, quality assurance, risk management

Subject matter expert on cleaning validation, process validation, quality assurance and quality risk management with more than 10 years of experience working in regulated pharmaceutical environment. My technical expertise covers many areas of product development, validation, quality assurance, and regulatory affairs, including – product / process design, development and validation, quality planning, root cause analysis, formulating CAPAs, risk assessment, technology transfer, equipment qualification, and dossier preparation and review. I also have extensive experience in technical writing including authoring policies, master plans, protocols, company procedures and reports. I am also proficient in analyzing, evaluating, trending and reporting quality and technical data.

Key Skills: Cleaning Validation; Process Validation; Analytical Procedure Validation; Quality Risk Management; Statistics; Training