Harsh Pandya

Manager Corporate Quality Assurance at Emcure Pharmaceuticals Limited

Based in Ahmedabad, India

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Seniority

Manager

Department

Other

Location

Ahmedabad

Industry

Pharmaceutical Manufacturing

Company size

9.2K

Contact information

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Email

1 credit

h•••••••@emcure.com

Phone

5 credits

+91 ••• •••• ••••

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Background

About Harsh Pandya

15 years of experience in technology transffer including project entry to project launch for US and regulatory territories with validation and subsequent troubleshooting with implementation of project timeline and resources mapping, cross function interaction, data analysis and mapping and fulfillment of regulatory documentation and day to day execution on floor. Also, have in depth idea of project entry @ formulation to project launch for US,EU and ROW markets. Also hands on experience of Quality management system, scale up, post approval support for immidiate and modified release formulations with complex mfg. technologies. Recently assigned a new role as subject matter expert (SME) in central investigation team under CQA involving holistic assessment of OOS/OOT, QMS, risk assessment, continous product life cycle assessment.

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