I have an overall work experience of over 14 yrs in the areas of Quality Assurance of both Sterile and Non sterile formulations and APIs. Extensive experience in Validations, Qualifications, Audits & Compliance in formulations and APIs
Executive - Regulatory & Documentation
Unichem Laboratories Limited, Ghaziabad – April 2003 to January 2004Joined as Executive-Documentation & Regulatory in formulation. Reviews manufacturing batch records for formulations for completion and accuracy. Assesses and tracks deficiencies and follow-ups. Develops trend reports for critical parameters and test results. Maintenance of approval status for all export products. Response to queries raised by regulatory agencies. Unichem Labs is an integrated pharmaceutical company exporting drug products to USA and Europe.
Sep 2006 - Present
Dr. Reddy’s Laboratories Limited, Hyderabad – Since August 2007 till date In my current role, I am responsible for Contract Manufacturing and Outsourcing of APIs and Intermediates for Quality Operations where I manage quality operations for over 30 sites. I am responsible for developing Quality strategy, and ensure that quality systems, processes and procedures are developed and implemented.
I organize transfer of technologies (ToT), process validations and coordinate with Plant, R&D, PPC, SCM and Vendors locations. Manages the Outsourcing Quality Operations in coordination with SCM In this capacity, I am supported by 2+ QA persons.
Since September 2006 to August 2007, Manager- QA, As a front line Manager, responsible for complete QA functions and ensures compliance to GMPs, Company policies-practices, procedures and regulations in API facility for highly potent APIs (cytotoxic) for regulated markets. Managing over a group of 3+ QA persons. Dr. Reddy’s Laboratories Limitedis a global generic pharmaceutical company having turnover of above 1.5 billion USD.
Jan 2004 - Sep 2006
Lupin Limited, Bhopal – January 2004 to September 2006Joined as Executive QA and elevated to Manager QA in APIs and formulations Quality Assurance. Responsible for Audits & Compliance. Manage, Review, and finalize audits and ensure compliance. Develop Internal Quality Audit Plan(s) and write Summary Report(s) - Review and approve Quality Performance Documents. Lupin Limited is one of the biggest Pharmaceutical manufacturer from India to launch a brand-Suprax in USA. The Bhopal site is having 7 APIs and 2 formulations plants.
Aug 2000 - Apr 2003
Panacea Biotec Limited, New Delhi – August 2000 to April 2003Joined as Officer QA and elevated to Executive QA. Review of Change Controls and tracking. Validations (e.g. facility qualification, equipment qualification, manufacturing process validation for dosage forms). Reviews manufacturing batch records for formulations for accuracy and completeness.