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. In 2021 Morison Sri Lanka, brought him on board as Chief Quality Officer-CQO, to achieve and realize the vision of the MD & Chairman to have a State-of-the Art facility at Homagama, Colombo. 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 respectively. As a Quality professional, 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 27 plus years 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, Intermediates/ KSM, API/ DS & DF Development. Supported the Dossier filing for developed markets and developing economies. Has setup the Global Quality organization for the Manufacturing Site (Multi-product manufacturing), Contract Manufacturing & Testing in regulated and semi-regulated markets.
He has founded the consulting firm, PharmaMantraTM, a Quality Advisory and consulting firm in August 2017. Since then he has performed at Global level – USFDA Remediation for Sterile and Non-Sterile Dosage forms for DS, Advise for the Greenfield, Brownfield and Quality Improvement Initiatives, Baseline/ CGMP GAP assessment, Due-Diligence Assessment, Mock USFDA & MHRA Audits, Mentored the Site Team during the EDQM/ USFDA, CGMP-Training, Toxicological Assessment/ PDE Certification, and Consulting assignments for Indian and MNC clientele. He has mentored the Top Management MD, Chairman others. He has proposed way-forward and Corrective Action Plan- CAP as compliance journey. He has worked closely with senior management to instill, sustain and maintain a Culture of Quality Compliance and win- back the trust with regulators. He envisions thorough PharmaMantraTM, he shall be able to provide the Manufacturing 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.
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