Jagruti Shah

Chemist Qs7 @Apotex Inc.

Analyzed Raw materials according to pharmacopeia by wet chemistry and advanced technology techniques Worked with management and colleagues to meet stringent deadlines and to maintain 100% schedule adherence Formulated and implemented investigation plans for out of specification results to identify root cause Selected to be subject matter expert for polarimeter and general wet chemistry testing Provided colleagues with updates for analytical techniques through literature and workshops Reviewed analyzed data and released material lots to meet production demands Routinely met rush deadlines for cleaning validation performed as per specifications and production needs Ordered laboratory chemicals, reagents, glass ware and testing equipment Oversees Method validation and technology transfer of methods between inter-sites and third parties and provide technical support Performed quality investigations of OOS results and other deviations of API, drug product, stability samples as per FDA guideline, cGMP and other regulatory requirement. Monitor treading of stability data and ensuring OOT/OOS investigations and provides feedback, assistance in the regulatory response and follow up on outstanding CAPA Quickly advanced from entry level to senior chemist role within department