Highlights:

Skills:

Manager Quality Assurance 05/2016 - current
Jubilant Life Sciences, Noida, Uttar pradesh India
Industry: Pharmaceutical Research and Development
Pharmaceutical project manager
Handling of NCE API projects manufacturing and testing for phase 1 and phase 2 clinical trials as a part of IND submission to USFDA. Collaboration with various US Clients for phase 1 studies as per the target deadlines. Management of client audits for site selection for manufacturing of products--
MANAGER QUALITY ASSURANCE 06/2012 - 05/2016
RANBAXY LABORATORIES LIMITED, GURUGRAM, Haryana India
Industry: Pharmaceutical Research and Development
Corporate Quality Assuarnce
Involved in review and approval of documents for ANDA submission for USFDA. Reviewed Analytical Method Validation reports, Formulation development reports, ICH stability reports, specification settings, Technology transfer documents, site audit, vendor audit--
Research Associate 01/2011 - 06/2012
Jubilant Life Sciences, Noida, Noida India
Industry: Pharmaceutical Research and Development
Analytical research and development
Analytical Method Development and Validation of Final APIs and solid oral dosage forms. Characterization of materials through pXRD, DSC, TGA techniques. Handling of Stability studies--

PUNJAB TECHNICAL UNIVERSITY 07/2005 - 06/2009
PUNJAB, Punjab, India
Degree: Bachelor's Degree
Major:BECHLOR OF PHARMACY
Minor:PHARMACEUTICAL SCIENCES
BECHLOR OF PHARMACY IN FIRST DIVISION

ARVIND SHARMA PHARMACEUTICAL QUALITY MANAGER