Seasoned, motivated and committed professional having an Operational & Industrial experience of 19 years pertaining to pharma plant finish dosage forms specialized in generic market, out of which 5 years as an Operations Head of multiple plants /site involved in generic, branded products manufacturing activities having regulatory approvals of US FDA & MHRA and other RoW
Seasoned, motivated and committed professional having an Operational & Industrial experience of 19 years pertaining to pharma plant finish dosage forms specialized in generic market, out of which 5 years as an Operations Head of multiple plants /site involved in generic, branded products manufacturing activities having regulatory approvals of US FDA & MHRA and other RoW approvals.
Strong techno commercial knowledge in Operational excellence pertaining to the site operations of 15 Billion OSD units per annum output.
Proven ability of leadership skills in operating the business conglomerate of 300 man power with
turnover of 400 Million USD on annual basis with consistent OTIF achievement at plant operations and
customer perspective across the globe of generic, branded supplies with sustainable efforts on
logistics of man, machines and materials apart from P& L related aspects of SBU of Pharma
Expertise in setting up of formulations site from inception to commercial stage with vast operations expertise of working in different roles & as Vice President / Operations Head in various companies with regulatory approvals of US FDA, UK MHRA, MCC – South Africa, MSF - France, NMA - Romania, TGA - Australia related to manufacturing and packaging activities of finished Pharma formulations in Tablets, Capsules, Dry Syrup, Liquid Orals and Parenteral (small volume Parenteral).
SLT - Senior Leadership Team member of formulations BU
- Evaluating the Execution of ANDA ‘s with QbD and DoE concepts to meet the compliance status of regulatory requirements at pre filing stage & Facilitation of Effective Formulation scale up and Process Engineering principles at commercial stage execution during post filing metrics.
Vice President-Operations @ Over all Operations head of the multi plant location site with US FDA approval with installaiton capacities of 1.2 Billion OSD per month & employing the man power of 2500 members inclusive of staff and Working personnel. Heading the BU for all techno commercial and P&L responsibilities. From February 2014 to Present (1 year 11 months) Associate Director @ Heading the manufacturing operations of all ANDA produced and filed by Dr. Reddy's accross India manufacturing locaitons (FTO 's).
Core member of manufacturing compliance and manufacturability assesment of all ANDA / Exhibit batches for US, EU and RoW & Risk mitigation and FMEA for all critical molecules from project introduction to Validaiton stage accross FTO 's. From January 2011 to February 2014 (3 years 2 months) Hyderabad Area, IndiaPLANT HEAD @ Operations Head for Unit III, which is the flag ship unit of entire Medreich India operations among MHRA and TGA approved sites. Used to handle techno commercial activities of entire BU which has got the installed capacities per month 150 Million OSD and 3 Million liquid oral units. Having the man power of 250 persons inclusive of staff and permanant work forces. From May 2009 to January 2011 (1 year 9 months) Production Manager @ Heading the sterile products (ANDA) and RoW, Domestic division for manufacturing and packaging. From 2008 to 2009 (1 year) Manager - Baddi Plant @ Handling the plant layout and development From March 2007 to July 2008 (1 year 5 months) Manager - Production @ Handling the production activities of solid orals and Injectables at Daman plant From May 2002 to March 2007 (4 years 11 months) Production Executive @ From March 2001 to May 2002 (1 year 3 months) Asst. Manager - Production @ Taking care of FDD and Production activities of Harmone produciton From January 1998 to March 2001 (3 years 3 months)
Pharmaceutical Sciences @ Gulbarga UniversityIPER Mallikh Arjun is skilled in: Faced the regulatory audits of US FDA, UK MHRA, MCC – south Africa, MSF - Fra, Preparation and Execution of Plant layouts effective scale up as per FDA norms, Cleaning Validation, Regulatory Affairs, GMP, Sop, Formulation, HPLC, Pharmaceutical Industry, GLP, Technology Transfer, FDA, Pharmaceutics, CAPA, Generic Programming
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