Experience

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  Chemino Pharma LTD

  • Vapi, Gujarat, India

  • SITE HEAD (OPERATION HEAD)

    • May 2023 - Present
    • Vapi, Gujarat, India

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  Innovassynth Technologies (I) Ltd.

  • India

  • Vice President of Production

    • Jun 2017 - Apr 2023
    • India

    Instituting & executing high level manufacturing strategies, making high-stake decisions and overcoming complex business challenges using experience-backed judgment, strong work ethics and irreproachable integrity  Spearheading continual excellence in execution of manufacturing schedules while developing resource requirement plans to meet the growth of the business Gained exposure in different types of drugs such as Nucleo(s)tide, and managing products like LNA (Locked nucleic acid), RNA (Ribonucleic acid) and different types of Nucleo(s)tide Preparing Master formula cards, Batch Manufacturing records and Batch Packing records for new products and other production related master documents and to get authorized the same from Quality Assurance Creating & sustaining a dynamic environment that fosters development opportunities and motivates high performance amongst team of 7 plants and 200 persons Appraising the prevalent production systems / processes, while identifying loopholes, if any and undertaking result-oriented measures for alleviating them and documenting the same Orchestrating the preparation of Ongoing Process Verification (OPV), Production Quality Risk Assessment (PQRA); streamlining standards, impurities for in process analysis by column chromatography for the API and intermediates; counselling and training team members by conducting knowledge transfer as Technology Transfer Scientist from lab to pilot plant

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  Apothecon Pharmaceutical

  • Vadodara, Gujarat, India

  • Deputy General Manager

    • Oct 2012 - Jun 2017
    • Vadodara, Gujarat, India

    Heading Manufacturing site, Outsourcing activities, Green field project experienceDeveloped production plan, mobilized and managed manpower, machines and material resources to optimize operational efficiency Directed the development & execution of APIs & administering API Lifecycle Management, Documentation, and Reports by incorporating robust Risk Assessment, Validation Processes, and API Project Management Supervised the management & modification of retro-synthesis of API & route of synthesis through the implementation of lean & QBD approach for achieving operational excellence Managed two small volume Manufacturing facility, and handled out sourcing activities(CRAMS) Resolved grievances of the Juniors and Operators to secure their total commitment to the assigned jobs Introduced and enforced quality systems / procedures to ensure strict adherence to specified quality norms Steered efforts in:o Production of the sterile Anticancer APIo Contract Manufacturing activitieso One small volume GMP project work completed for planning, designing, installation,execution up to GMP certificationo One big GMP ONCOLOGY for sterile API plant project completed for planning,designing, installation of various isolators, execution up to GMP certificationAudits Faced: MHRA audit faced in September-2015 under my leader ship US FDA audit faced in October-2015 under my leader ship Various costumer audits faced

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  Emcure Pharmaceuticals Limited

  • Kurkumbh Maharashtra Indian

  • Production Manager

    • Sep 2010 - Sep 2012
    • Kurkumbh Maharashtra Indian

    Heading Oncology facility, faced regulatory audits successfully.  Headed Plant operations of API-5 Oncology and multipurpose general Active Pharmaceutical ingredient manufacturing Managed end-to-end plant activated, day-to day-production, production planning and so on Conceptualized production plans; monitored inventory of raw material, catalysts & chemicals while ensuring smooth operations  Monitored the overall process, resolved problems as well as technical issues and ensured product quality improvement by using various initiatives  Steered production of the sterile Anticancer APAudits Faced: US FDA audit faced in October-2011 under my leader ship BMS audit faced as a plant in charge Various costumer audit faced

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  Aarti Industries Ltd.

  • Boiser Maharashtra India

  • Assistant Manager

    • May 2007 - Sep 2010
    • Boiser Maharashtra India

    Heading two Individual plants, General API and Oncology API. Managed plant of Block-01 multipurpose general Active Pharmaceutical ingredient Responsibilities:manufacturing. Over all plant handling activity, day to day production, production planning and so on Administered plant management of Block-03 anticancer Active Pharmaceutical IngredientManufacturing Managed diverse range of production activities such as execution of strategic plans, process &equipment handling, capacity utilization, process control, cost management, audits & inspectionand quality assurance Led process improvement, lean manufacturing, cost reduction projects and implemented qualitysystems for enhancing production efficiency; enhanced the efficiency of workforce Worked under Makenzy project for the cost reduction and capacity enhancement Spearheaded the entire validation activity from TTD to filing Developed people for safety and environmental activity through proper guidance and training Prepared the documents related to the new facility installation like URS, DQ, IQ, OQ, PQ Audits Faced: US FDA audit faced in May-2004 as a plant in-charge US FDA audit faced second time in March 2008 as a plant in-charge EDQM audit faced in March 2005 under my leader ship EUGMP audit faced in January 2008 leader ship Various customer audits faced

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  Zydus Group

  • Vadodara, Gujarat, India

  • Production Executive

    • Aug 2002 - Apr 2007
    • Vadodara, Gujarat, India

    Heading Individual plant, Led all phases of plant operations including production planning, production, quality control, and maintenance Faced US FDA, and other regulatory audits Determined the long & short-term goals to ensure positive results in the areas of manufacturingpractices

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  DISHMAN PHARMACEUTICALS AND CHEMICALS LIMITED

  • Ahmedabad, Gujarat, India

  • Senior production officer

    • Apr 1997 - Jul 2002
    • Ahmedabad, Gujarat, India

    works on pharmaceutical drugs, fine chemicals.