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 performed Training, GAP assessment Audit, Site support during EDQM/ USFDA, Toxicological PDE Certification, and 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.
Since, March 25th' 2020; PharmaMantra adopted seamlessly to the need and catered the exigency caused due to Pandemic – Covid-19; during subsequent Lockdown we provided the remote review & assessment for developed Markets like USFDA, EU region – QMS Review, Batch Record Review and Release of the Sterile Finish Products. Proposed the WL Remediation strategy, Plan and CAP. Virtual CGMP Audit and due diligence. Virtual Training and mentoring and advisory for Global corporations.