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Founder
Udaykumar is a quality professional with a dynamic career steering organization through complex Quality & Regulatory challenges, transitions, building an empowered and talented workforce in the cross-cultural environment within highly competitive products and regulatory environment.
In Year 2006, as Director - Quality Assurance, he was mandated and given the task to execute and spearhead the proactive remediation at Ranbaxy Lab. Ltd. Subsequently since Daichii Sankyo takeover, he was made Head, India and Asia Quality Operations and overseeing the state of control. In late 2011 he was recruited by Intas Pharma Ltd. to create a self-sustaining quality management system and enhance inspection readiness. Further, in 2013 he was hand-picked & recruited by Wockhardt Ltd., as Senior Vice President – Quality, to turn around the Quality Management, lead and manage the remediation of Quality initiatives. He has represented the Organisation as Quality Head and prepared, presented and attended the regulatory meetings with IAG/ MHRA/ IMB/ USFDA at London and Washington. Has performed 400+ Audits and faced 500+ regulatory audits.
He began his career in Quality function as an Executive In-process QA and then moved to different levels and organization spanning 3 decades of hands-on and hard-core experience in the pharmaceutical regulatory environment. He has gained the domain experience in Quality & Operations, specifically focusing and leading the Quality & Regulatory remediation in last 12 years (2006-2017). He has worked for a decade in Corporate Quality functions, overseeing the Project Management, Toxicological Assessment, Clinical, BA/ BE, API & DF Development & Dossier filing for developed markets and developing economies. Has setup the Global Quality organization for the Manufacturing Site (Multi-product manufacturing), Contact Manufacturing & Testing in regulated and semi-regulated markets.
He has founded PharmaMantraTM, August 2017, a Quality Advisory Consulting firm. Since then he has advised management teams, at top of pyramid like- CXO, Technical Teams & also at shop floor & bench levels at sites, R&D. In past six years, he has advised reputed, esteemed MNC clientele spread across all geographies and continents. The various services provided are such as, Training, Advisory, Consulting, Training, GAP assessment Audit, Site support during EDQM/ USFDA, Toxicological PDE Certification. On site & off-site mentoring, training, advisory, consulting assignments for Indian and MNC clientele.
He has advised and supported API, DF site in formulating response to the Warning Letter, FD-483 & MHRA/ EDQM/ EU audit observations. Helped to evolve a CAP - Corrective Action Plan and worked with senior management to maintain a culture of compliance and trust with regulators. He envisions thorough PharmaMantraTM, he shall be able to provide the Manufacturing, Regulatory and Quality Leaders the desired insights and advice to reach simple sustainable solutions for the seemingly complex situations/ problems/ activities. He has experience which can be shared and adopted for various stages of the Quality System developments and subsequent evolution to demonstrate the desired Culture of Pharmaceutical Quality.
Doctor of Philosophy (Ph.D.), Pharmacy
Dr. Babasaheb Ambedkar Marathwada University, Aurangabad (2014 – 2019)
MBA, Logistics, Materials, and Supply Chain Management
J.D.C. Bytco Institute of Management Studies & Research, Nashik (1992 – 1994)
B.Pharmacy and M.Pharmacy, Pharmaceutics
MVP Samaj's College of Pharmacy, Nashik (1985 – 1991)
HSC, Biology/Biological Sciences, General
Gokhale Education Societys H.P.T. Arts & R.Y.K. Science College, Nashik (1983 – 1985)
Founder
PharmaMantra™ (Aug 2017 – Oct 2023)
Chief Quality Officer
Morison Limited (Dec 2021 – Jan 2023)
Senior Vice President (Quality)
Wockhardt Ltd. (Aug 2013 – Jul 2017)
Senior Vice President (Quality)
Intas Pharmaceuticals Ltd. (Nov 2011 – Aug 2013)
Director Quality Operations/ Head DF India & Asia Quality Operations
Ranbaxy Labs Ltd. (Aug 2006 – Oct 2011)
Associate Director (Corporate Quality)
Ranbaxy Labs Ltd. (Nov 2000 – Dec 2006)
GM (Quality Affairs)
Glenmark Pharmaceuticals Ltd. (Apr 1999 – Nov 2000)
Manager (QA)
Dabur Pharma Ltd. (Apr 1997 – Mar 1999)
Executive IPQA
Ranbaxy (Oct 1995 – Mar 1997)
Executive QA
Glenmark Pharmaceuticals Ltd. (Feb 1991 – Oct 1995)
Summer Intern
GSK (Jun 1988 – Aug 1988)
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