Ritesh Gupta

Ritesh Gupta

Officer

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location of Ritesh GuptaVadodara, Gujarat, India

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  • Timeline

  • About me

    Production Head(DGM)|Faced USFDA audit as direct auditee in April 2023 with ZERO 483 observation|Planning|Yield|Capacity| Production planning|cGMP|safety|tech transfer|Audits(USFDA)|investigation| costing| CAPEX|Training

  • Education

    • Institute of Science & Technology for Advanced Studies & Research (ISTAR) Vallabh Vidyanagar

      1999 - 2001
      Master of Science - MS Industrial Chemistry Distinction

      Activities and Societies: Industrial chemistry Completed 02 years full time course from reputed institute & Sardar Patel University with Distinction.

    • Kendriya Vidyalaya

      1994 - 1994
      SSC Science Distinction

      Activities and Societies: Science Completed SSC from CBSE board( English medium).

    • Kendriya Vidyalaya

      1996 - 1996
      HSC Science Distinction

      Activities and Societies: Science Completed HSC from CBSE board( English medium).

    • Sardar Patel University, Vallabh Vidyanagar

      1996 - 1999
      BSc Industrial Chemistry First

      Activities and Societies: Industrial chemistry

    • Sardar Patel University, Vallabh Vidyanagar

      1999 - 2001
      Master of Science - MS Industrial Chemistry Distinction

      Industrial Chemistry is a course having syllabus equivalent to Chemical engineering & teaches both unit operations & unit processes in depth.

    • Kendriya Vidyalaya

      1996 - 2001
      Bachelor of Applied Science - BASc Industrial chemistry Distinction
    • Birla Institute of Technology and Science, Pilani

      2010 - 2011
      MS( Pharmaceutical operations & Management) Pharmacology,pharmaceutical science, Distinction

      2 years course having curriculum regarding pharmacology,pharmaceutical science,drug design,clinical trials,accounting.

  • Experience

    • Lupin

      Jan 2001 - Jan 2005
      Officer

      Shift productionHandling a section of Ethambutol Plant.Taking Charge of Shift Supervisor

    • Zydus Group

      May 2005 - May 2006
      Officer-production

      Responsible for shift related activities,manpower control,calibration of instruments,communication with QA department,dispensing of RM,solvent & packaging material,cGMP related document preparation,Highlighting gap to meet cGMP requirements

    • Lupin

      May 2006 - May 2015
      Senior Executive-Shift production

      Worked as Plant Incharge, Responsible for a multi product, USFDA approved, API manufacturing facility with a team size of 25 members.

    • Zydus Group

      Sept 2015 - May 2017
      Production Manager

      Manager-Production- heading a multi product USFDA approved API manufacturing facility with team size of 25 members.

    • Ipca Laboratories Limited

      May 2017 - Jun 2018
      Senior Production Manager

      Production Head-02 API manufacturing facilities (Hormones).Second line to Unit Head.Heading a team of 37 members

    • SPC Lifesciences Pvt. Ltd

      Jun 2018 - Sept 2019
      Senior Manager -Production & Operations(Site Head)

      Operations Head

    • Alkem Laboratories Ltd.

      Sept 2019 - Nov 2023

      Leading entire production activities & a team of 77 team members.Successfully faced USFDA audit in April 2023 with zero 483 observation.Production planning of different products on campaign basis,raw material planning,continous working of capacity enhancement,yield improvement & people development.Facing audits directly(USFDA,TGA,EDQM,statutory,GPCB,boiler inspector,excise inspectors & CWC).Implementation of 5S,Six Sigma & Kaizen principles at shop floor.Ensuring compliance to QMS documents,safety & other statutory requirements.Technology transfer of the products.Commissioning of plants for API manufacturing.Handling softwares like SAP,Trackwise,Nichleon,e-DMS & imparting training to colleagues & subordinates.Investigation of failures(OOS,OOT,Deviation,market complaint) & accidents/incidents.Process optimization & cost reductionCapacity enhancement & yield improvement.Budgeting & CAPEX.Validation & QMS documents.Reporting to Sr GM- Production. Show less

      • Production head( Senior Manager)

        Sept 2019 - Nov 2023
      • Production Manager

        Sept 2019 - Sept 2019
    • Glenmark Life Sciences

      Oct 2023 - now
      Deputy General Manager

      Responsibility of plethora of Production activities (USFDA approved site).

  • Licenses & Certifications

    • Lead the organization in achieving a turnover of 107Cr from 66 Cr within one financial year

      SPC Life sciences Pvt Ltd
      Jun 2018
    • Green belt-Six Sigma

      Lupin
      May 2014
    • Certified recruiter

      Alkem Laboratories Ltd.
      Jul 2020
    • Appreciation for leading USFDA audit with zero 483 observation

      Alkem Laboratories Ltd.
      Apr 2023