
Ritesh Gupta
Officer

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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 - 2001Master of Science - MS Industrial Chemistry DistinctionActivities and Societies: Industrial chemistry Completed 02 years full time course from reputed institute & Sardar Patel University with Distinction.

Kendriya Vidyalaya
1994 - 1994SSC Science DistinctionActivities and Societies: Science Completed SSC from CBSE board( English medium).

Kendriya Vidyalaya
1996 - 1996HSC Science DistinctionActivities and Societies: Science Completed HSC from CBSE board( English medium).

Sardar Patel University, Vallabh Vidyanagar
1996 - 1999BSc Industrial Chemistry FirstActivities and Societies: Industrial chemistry

Sardar Patel University, Vallabh Vidyanagar
1999 - 2001Master of Science - MS Industrial Chemistry DistinctionIndustrial Chemistry is a course having syllabus equivalent to Chemical engineering & teaches both unit operations & unit processes in depth.

Kendriya Vidyalaya
1996 - 2001Bachelor of Applied Science - BASc Industrial chemistry Distinction
Birla Institute of Technology and Science, Pilani
2010 - 2011MS( Pharmaceutical operations & Management) Pharmacology,pharmaceutical science, Distinction2 years course having curriculum regarding pharmacology,pharmaceutical science,drug design,clinical trials,accounting.
Experience

Lupin
Jan 2001 - Jan 2005OfficerShift productionHandling a section of Ethambutol Plant.Taking Charge of Shift Supervisor

Zydus Group
May 2005 - May 2006Officer-productionResponsible 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 2015Senior Executive-Shift productionWorked 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 2017Production ManagerManager-Production- heading a multi product USFDA approved API manufacturing facility with team size of 25 members.

Ipca Laboratories Limited
May 2017 - Jun 2018Senior Production ManagerProduction Head-02 API manufacturing facilities (Hormones).Second line to Unit Head.Heading a team of 37 members

SPC Lifesciences Pvt. Ltd
Jun 2018 - Sept 2019Senior Manager -Production & Operations(Site Head)Operations Head

Alkem Laboratories Ltd.
Sept 2019 - Nov 2023Leading 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 2023Production Manager
Sept 2019 - Sept 2019

Glenmark Life Sciences
Oct 2023 - nowDeputy General ManagerResponsibility 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 LtdJun 2018
Green belt-Six Sigma
LupinMay 2014
Certified recruiter
Alkem Laboratories Ltd.Jul 2020
Appreciation for leading USFDA audit with zero 483 observation
Alkem Laboratories Ltd.Apr 2023
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