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Lalit Kumar Dwibedi

Current Role

Talent
House # B 103, Satyabadi Residency, Kalarahanga, Bhubaneswar, PIN-751024Member since July 7, 2026
Quality Management System (QMS)Vendor Audit and Management (RM-API/Excipient and PM)Validation & Qualification (Equipment, Utility, Facility, Product and Cleaning)Injectables (Liquid and Lyophilized Powder)Oral Dosage Form (Tablet, Capsules, Liquid and lozenges)External Preparation (Ointment, Cream and Lotion)Inhaler (Metered Dose Inhaler, Dry Powder Inhaler and Nasal Spray)Audit, compliance and remediation
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Quality Management System (QMS)Vendor Audit and Management (RM-API/Excipient and PM)Validation & Qualification (Equipment, Utility, Facility, Product and Cleaning)Injectables (Liquid and Lyophilized Powder)Oral Dosage Form (Tablet, Capsules, Liquid and lozenges)

About

Interested for assignment to be part of organizational team that has the potential of recognition, utilization and enhancement of my skills.

Experience

Current Role - Seemanta Institute if Pharmaceutical Sciences - Jharpokharia, Mayurbhanj, Odisha

  • Responsible for completion of academic syllabus and imparting classes as assigned
  • Responsible for compliance to Govt. authority's (PCI, BPUT, OUHS and OSBP) observations
  • Responsible for Training and Placement Cell to ensure 100 % job guarantee
  • Collaboration with teaching, non teaching and management staff for smooth college functioning

Principal - Nupoor Collage of Pharmacy - Raipur, Chhattisgarh

(2022-07 - 2026-03)

  • Overall administrative functioning of college
  • Handling Inspection and Govt. authorities required for college functioning
  • Collaboration with teaching, non-teaching and management staff for smooth college functioning and Budget management

Manager MPD (Material Process and Delivery) - P&G (Erstwhile Teva Pharmaceuticals) - Sanand, Ahmedabad, Gujrat

(2016-07 - 2022-06)

  • Technology transfer and new product development in coordination with R & D
  • Validation - Process and cleaning
  • Vendor Management - Site Material Leader (RM-API/Excipient and PM)
  • Audit and Compliance
  • Site Business Continuity Leader (BCP Lead)
  • Regional Sensory Coordinator

Manager Validation - Sun Pharmaceuticals Ltd. (Erstwhile Ranbaxy) - Mohali

(2014-11 - 2016-07)

  • Qualification (3Q) of Equipment, Utility and Facility
  • Complete Consent Decree (CD) Remediation Project for Qualification/Validation

Assistant Manager - Glenmark Pharmaceuticals Ltd. - Baddi

(2012-04 - 2014-11)

  • Qualification (3Q) of equipment, utility and facility
  • Conduct and face internal and external Audits (USFDA, MHRA, ANVISA, INVIMA etc.)
  • Preparation and review of VMP, SMF, and Vendor Management (Service provider)
  • Cleaning and Process Validation
  • QC compliance
  • Review and evaluation of Incidences, Deviation, Change Control, OOT, OOS etc.

Executive - Fresenius Kabi Oncology Ltd. - Baddi

(2010-05 - 2012-04)

  • Planning and execution of qualification and validation of equipment - Autoclave, Depyrogenating Tunnel, DHS, Terminal Sterilizer, Lyophilyzer, HVAC System, LAF, CRAB, Isolator, Vial Washing Machine, SIP and CIP System, Incubator, Stability Chamber etc.
  • Cleaning Validation
  • Vendor Management (API and excipient)

Junior Manager - Dr Reddy's Lab. Ltd. - Baddi

(2007-03 - 2010-05)

  • QMS activity
  • Validation of process, utility & equipment in coordination with concerned department without hampering Productivity and Quality
  • Initiation and closing of Change Control, incident and deviation in time
  • Key member in Vendor Audit Team
  • Key member in Lean Management Team
  • Key member in Value Addition Process Team
  • Key member in 5S Team

Management Staff - QA - Cipla Ltd. - Unit –IX, Goa

(2005-01 - 2007-02)

  • Validation of Equipment, Utility and Facility for effective Production as per organizational planning

Production Trainee - I.D.D. Pvt. Ltd. - Cuttack, Odisha

(2003-08 - 2004-11)

  • Proper manpower utilization
  • Maintain and filling Batch Records (BMR and BPR)
  • Prepare (DPR) daily production report and follow daily production planning in coordination with RM/PM vendors
  • Ensure cGMP and SOP
  • Co-ordination with QC, QA and maintenance, for quality production in time

Education

M. Pharm - Pharmaceutics - Biju Patnaik University of Technology (BPUT) (2013)

B. Pharm - Pharmacy - Seemanta Institute of Pharmaceutical Sciences (2003)

H.S.E. - Govt. College Rourkela (1998)

A.I.S.S.E. - J.N.V. Hadagarh (1996)

Skills

Current Role

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