Sandeep Sheth

Sandeep Sheth has worked in the pharmaceutical industry since 1989. From 1989 to 1999, they worked at IMS Ltd as a Chemist/Senior Chemist and QA Inspector. Sandeep'sduties included drafting stability indication assay method validation protocols, executing protocols, writing reports for regulatory submission, testing air and surface bioburden levels for viable and non-viable particles in Class 100 fill rooms, reviewing batch records for various injectables for accuracy and compliance issues, training personnel for aseptic gowning procedures, and reviewing autoclave-oven charts.

From 1999 to 2007, Sheth worked at GRAM Laboratories, Inc. as a Laboratory Manager. Sandeep'sduties included setting up the laboratory from the beginning stage, establishing various SOPs for maintenance, operation, and calibration of equipments/instruments.

From 2007 to 2009, Sheth worked at GRAM Laboratories, Inc. as a Quality Assurance Manager. Sandeep'sduties included managing FDA inspections solely for ANDA approvals and cGMP, managing product development resulting in 11 ANDA approvals, and managing laboratory audits conducted by various pharmaceutical companies.

From 2009 to 2012, Sheth worked at Teva Parenteral Medicines as a Stability Laboratory Operations, Group Leader. Sandeep'sduties included managing R & D stability testing program for about thirty parenteral products for regulator submission, managing three supervisors along with four analysts, being responsible for five most critical aspects of stability studies, being responsible for timely completion of OOS/OOT and Deviations, and being responsible for company's "Remediation activities" for one third of commercially manufactured products.

Finally, from 2012 to present, Sheth has worked at Best Formulations as a Quality Control Laboratory Manager. Sandeep'sduties include daily laboratory activities such as releasing of Raw Materials, Finished product, Stability testing, Micro testing, Method development/Method validation, NCR/OOS/Deviation/CAPA activities, troubleshoot/OQ/IQ/OQ instruments, yearly budget preparation, and managing the outside testing. Sandeep also manages a staff of a supervisor and 15 laboratory personnel to meet high pace high volume commercial product testing in cGMP environment. Sandeep established method development and method validation program.

Sandeep Sheth obtained a MS in Analytical Chemistry from Gujarat University between 1982 and 1984. Prior to that, they obtained a BS in Chemistry from Gujarat University between 1978 and 1981, with a focus on Organic, Physical, and Inorganic Chemistry.