Manager
Current· Carrying out complete testing of new product development with stability study for Europe, US and rest of world countries market in accordance with the ICH guidelines· Responsible for planning of analytical development work· Performing review and compilation of results· Assisting in activities of method development as well as implementation of CGLP in lab· Monitoring & reviewing of SOP and its implementation to ensure quality· Involved in archiving analytical data’s for regulatory submission· Coordinating in carrying out outsourcing analysis of API and products· Performing review of raw material, excipients, in-process and finished product STP’s and specification· Performing vendor qualification activities· Performing in vitro dissolution, comparative dissolution including multimedia dissolution testing