Quality-focused professional with over 13 years of experience in Pharmaceutical Operations focusing on maintaining quality system controls through analytical research procedures, degradation pathways, and product development across US and European market. Attained proficiency in leading Analytical Team over Method Development, Method Validation/Transfer, standard testing procedures, Outsourcing analysis, Filings, etc. through HPLC, UPLC, GC, & UV methods.
Dexterous in Quality Management System such as Deviation, CAPA and Change control, procedural development, metrics tracking, process improvements by conducting the Internal Audits adhere to QMS/GLP/cGMP and strong knowledge on ICH Guidelines, USFDA Guidelines, 21 CFR Part 11, 210 & 211. Skilled at preparation & review of SOPs, protocols, validation reports, and methods transfer Protocols/Reports as per ICH guidelines
Proven ability to lead teams in a cross-functional, challenging and a matrix-driven environment ensuring strict adherence to project-specific goals, timelines and professional integrity