Experienced Analytical chemist with a demonstrated history of working in analytical method development and method validation using HPLC, GC, LCMS. Performed analysis of stability samples of Drug products, Drug substances following ICH Q1A-Q1F guidelines. Prepared trend data sheets, OOS, OOT's.Framing of specification's and Standard testing procedure's.Assay of nasal inhalers using Anderson cascade impacterExpertise in purification and isolation of drug active, related substances and degradation productsIn case of a testing failure, immediately reported to the Department Head or the designee before proceeding further with the test, lead/assist failure investigations to identify the cause of failure and prepare a deviation report and/or Corrective Preventative Actions (CAPA) if it is appropriate.Strong analytical problem solver with a detail oriented attitude. Easily adaptable to the fast paced work environment Transfer of technology to manufacturing sitesExperienced in solving regulatory queries for ANDA, NDA