Saurabh Varshney
Cal Head R & d Gurugram @SUN PHARMA
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WORK HISTORY
Cal Head R & d Gurugram @SUN PHARMA
Gurugram, IN
Handling a team responsible for analytical method validation and method transfer for APIs and drug products across regulated markets involves a highly specialized and strategic role in pharmaceutical quality control
EDUCATION
Manipal Academy of Higher Education
Master's in pharmacy, Pharma
ABOUT SAURABH VARSHNEY
Over 20+ years experience in analytical method development, method validation and method transfer for chacerization of API,s and various dosage forms.*Strategic planning and guidance for execution of analytical method development, analytical method validation and analytical method transfer.*Bioequivalence dissolution test to comply \"Guideline for bioequivalence studies of generic products\" for Japan market.* Exceptional problem solving skills, led GMP team to identify root cause for OOS during method validation and method transfer.*Experience of setting up of highly effecient to analytical lab, created and implemented quality system.*AqBd approach for life cycle management for analytical perspective.*Experience of USFDA audit.*Sound knowledge for recent regulatory requirements of ANVISA guidelines.
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