Udaykumar Rakibe

About Udaykumar Rakibe

Demonstrated track record, by leading cross functional global teams to achieve desired tactical, strategic business objectives with continued assurance of product quality and GMP compliance. Proven expertise in defining organizational structure for Quality Management and align Quality function with the Business objectives/ goals. Articulate communicator, highly skilled influencer, negotiator. Identified and streamlined Quality System - Harmonisation and Digitisation. A highly motivated result oriented professional with about three decades domain experience in the pharmaceutical quality management in regulatory GXP/GMP arena. Spearheaded the task of developing, formulating and implementing a global remediation plan & strategy. An accomplished professional, worked in WL & Import Alert remediation and CAP. In past one decade faced and participated in 450+ Regulatory Audits, and in the corporate role globally performed 400+ due diligence/ Audits. Enabled, trained and empowered operations teams to steer through the regulatory challenges posed by ever increasing expectations of MHRA/ EU & US-FDA.Value – • Trustworthy, Truthful, Honest • Dependable, committed to excellenceSkills –• Instilling Culture of Pharmaceutical Quality• Mentorship & Leadership, Articulate Communicator, Listener & Influencer• Strategic thinking & task orientation for remediation activitiesDeliverables –• Lead and mentored large teams, with supervising 10+ direct reports• Building Strategic planning and execution of plans, project management• Planning and Leading regulatory and vendor/ supplier audits• Review and development of Quality Management Systems• Budgeting and controlling, Budget of the 3rd party and contract manufacturing• Developing and Launching new products with 3rd party RnD and operations team• Training and development, Organising workshops Guidelines for 3rd party/ partners

Experience

1. Founder

   Pharmamantratm

   Aug 2017 — Present · Nashik, IN

   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. 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 has founded the consulting firm, PharmaMantra, a Quality Advisory and consulting firm in August 2017. 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 proposed Corrective Action Plan and worked with senior management to maintain a culture of compliance and trust with regulators. He envisions thorough PharmaMantra, 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.

Education

• Gokhale Edcuation Societys H.P.T.Arts & R.Y.K.Science College, Vidyanagar, Nashik 422005

  HSC, Biology/Biological Sciences, General

  1983 — 1985

• Gokhale Edcuation Societys H.P.T.Arts & R.Y.K.Science College, Vidyanagar, Nashik 422005

  B.Pharmacy and M. Pharmacy, Pharmaceutics

  1985 — 1991

• J.D.C.Bytco Institute of Management Studies & Research, Nashik 422005

  MBA, Logistics, Materials, and Supply Chain Management

  1992 — 1994

• Kendriya Vidyalaya

  CRPF, Jhadoda Kalan, Class Fourth, Middle

  1976 — 1977

• Dr. Babasaheb Ambedkar Marathwada University, Aurangabad

  UDCT- Doctor of Philosophy Ph.D., Pharmacy

  2014 — 2019

• Kendriya Vidyalaya

  Janakpuri, N. Delhi, First to Third, Middle

  1972 — 1976

• Kendriya Vidyalaya

  Bhatinda Cantt. Eighth and Ninth, Middle School

  1980 — 1981

• Kinder Garten Air Firce Station, Palam, N. Delhi

  Pre-schooling, Elimentry

  1971 — 1972

• Kendriya Vidyalaya

  Ojhar SSC, Tenth in School, SSC

  1982 — 1983

• Kendriya Vidyalaya

  Vayusena Nagar, Nagpur, Fouth to Eighth, Middle School

  1977 — 1980