Summary
Overview
Work History
Education
Skills
Volunteer Experience
Hobbies and Interests
Awards
Personal Information
Affiliations
Accomplishments
Languages
Timeline
Generic
Guruprasad Bahiropatil

Guruprasad Bahiropatil

Mumbai

Summary

Dynamic leader with extensive experience in supply chain management and strategic sourcing at Cipla Ltd., adept at driving operational excellence and quality management. Skilled in SAP and fostering team collaboration, I've successfully enhanced production efficiency by 20% and implemented cost-saving strategies, demonstrating strong problem-solving and leadership abilities.

Overview

13
13
years of professional experience

Work History

Lead Sterile Operation, Finished Product Sourcing

Cipla Ltd.
Mumbai
04.2024 - Current
  • Managed Global strategic Formulation sourcing of Sterile and Non-sterile finished products from LL and P to P sites for both domestic and international regulated markets, utilizing SAP integrated business planning for supply chain optimization in regulated and non-regulated market.
  • Supports end to end supply chain planning and optimization of finished products, including Sterile products (Vials: Aseptic filtration/Terminal sterilization liquid, Lyophilized, Dry powder; Pre-filled syringes: aseptic filtration/terminal sterilization liquid; aseptic cartridges; infusion bags; ampoules: clear and amber: aseptic filtration/terminal sterilization; BFS respules; ophthalmic bottles: 2/3 piece eye drops; freeze-dried vaccines; immunotherapy allergen vaccines; diagnostic test kits: skin prick test) and non-sterile products (oral solid dosage tablets: coated, uncoated, bilayer, sugar-coated, effervescent, sublingual; capsules: hard gelatin, soft gelatin; aerosol topical nasal spray; topical semi-solid creams/ointments: general and corticosteroid)
  • Optimized Quality Management & compliance through periodic gap assessment of product and process, Cipla quality policy, Global regulatory compliance includes Revised Schedule M, EU-Annex1, TGA, ANVISA and USFDA
  • Increase manufacturing agility & visibility (meet demand in every market with connected manufacturing operations & business data)
  • Involved in Project management, Process simplification, Process optimization, resource allocation, cross functional collaborations for smooth problem solving, Operational Excellence Effectiveness(OEE) and cost saving strategy implementation
  • Monitored and co-ordinate with CMO for New Product introduction, technology transfer and commercial of developed product with highest product OTIF (On-Time In Full)
  • Managed Preliminary technical evaluation in Alternate Vendor Development (AVD) and vendor management
  • Initiate New site review preliminary audit, compliance & New site approvals to meet increase in market requirements, Ensure robust road map for start-up of new CMO sites
  • Automation review, score cards and implementation at respective site. Drive improvement of Automation at respective site and conduct regular review.
  • Schedule Regular meeting with CMO Senior management at unit about the observations and Upgradation plans and track the improvement plans
  • Investigate Market Complaints, OOS, OOT, OOL, Investigations and CAPAs jointly with the team and CMO through root cause analysis to resolve critical issues in a timely manner
  • Review Daily/Weekly report/Monthly report sent by site representatives and production coordinators and track the observations regularly and take immediate action for critical observations from reports along with CMO's mgmt., Review site performance wrt. quality, automation and bottleneck at site
  • Workplace safety management risk mitigation
  • Drive training and development for the production coordinators and site representatives

Production Manager

Gland Pharma Ltd.
Hyderabad
06.2021 - 04.2024
  • Oversaw production schedules, ensuring timely delivery of high-quality products Sterile Injectables Drug Product manufacturing in Vial and Ophthalmic line and which includes Daily activity mapping of Compounding & Filling along with component pre-requisities activities to meet customer demands
  • Implemented cost-saving initiatives, yield consistency & Monthly plan Vs Actual Dashboard with No
  • Of unitsthat resulted in a 10% reduction in production expenses
  • Managed a team of 65+ employees, providing training and guidance to maximize productivity and efficiency
  • Collaborated with cross-functional teams to improve processes and streamline workflow, resulting in a 20% increase in production output

Production Deputy Manager

Biological E. Ltd.
Hyderabad
02.2019 - 05.2021
  • Implemented quality control procedures like EU-Annex 1 gap assessment, Contamination Control Strategy document, Cross Contamination Strategy in site risk assessment, pFMEA and Aseptic Process Simulation (APS) risk assessment for Ad26.COV2.S vaccine which coresulting in a 15% decrease in production errors
  • Coordinated scheduling and workflow to optimize production efficiency, leading to a 20% increase in output in Td, TCV & LPV drug product manufacturing
  • Managed a team of 55 production workers, providing training and support to improve overall performance
  • Collaborated with cross-functional teams to streamline communication and ensure seamless operations throughout the production process such as Vial washing, Vial depyrogenation tunnel, Vial filling and Stoppering, Vial sealing, Automatic Vial collection tray loader and in-process visual inspection of washed and sealed vials, seal integrity through CCIT method
  • Vendor selection for Single use systems(SUS), Container Closure Integrity (CCI) study at different crimping pressure of sealing machine, Spallation study of silicon tubing for particulate matter analysis by using Light Obscuration test, AP1 buffer preparation in Thermo-Fisher Single use mixer(SUM), Thawing of Ad26.COV2.S drug substance PC bottles Filtration of AP1 Buffer and DS using opticap XL 10 filter (Size: 0.2 micron), Formulation, Usage of PUPSIT (Pre Use Post Sterilization Integrity) filtration assembly (0.2 micron redundant filter) PP Filling assembly for filling operation, capping and collection of vials in Auto Visual Inspection (AVI) machine
  • Initiation and timely closure of Change controls and Deviations (Subsequently Investigation) through Trackwise software as a Production QMS compliance coordinator
  • Mainly responsible for departmental Training Coordinator (TC) and Course Administrator (CA) role through LMS software for Electronic based SOP training system
  • Involved in Aseptic media simulation of Td & LPV 10 dose for 5mL vial presentation, Td & LPV Single Dose for 3mL vial presentation and TCV 5 Dose for 3mL vial presentation
  • Responsible for New material code creation, Requisition, maintaining stock and reconciliation of Material like Critical Process Consumables (CPC), Consumables, Raw materials and packing consumables through Material indent software like BE MDM, BE PURE & BE MARS
  • Responsible for document preparations like Master Formulation Record (MFR) for Td 10Dose, LPV 10Dose & TCV 5Dose, Quality Risk Assessment (QRA) for General process, Td 10Dose, LPV 10Dose & TCV 5Dose, Standard operating procedures for equipment operations and process (Pooling of RTF containers in filling vessel, Assembling of filling components and Intervention procedure during batch manufacturing and air flow direction), Filling process, Visual Inspection, Packing and Dispatch related, Aseptic Simulation protocol and ROR, Process Validation protocols and Record of Results (ROR), Cleaning validation protocol (DHT & CHT) and Record of Results (ROR), BPR for Pooling and Filling of Tetanus and Diphtheria (Adsorbed Reduced Antigen) 10Dose, BPR for Typhoid Conjugate Vaccine (Monovalent)2.5mL presentation, BPR for Manual visual inspection for Tetanus and Diphtheria (Adsorbed Reduced Antigen) 10Dose, Placebo trial batches for Td Vaccine
  • Responsible for SAP entries after completion of batch includes Process order creation & it's modification, create reservations of materials, Goods movement postings such as Goods issue or receipt in inventory management and also for physical inventory postings, Bill of Material(BOM), Work center, handled modules like COR1, COR2, MIGO (Goods issue and Goods receipt), COR6, MMBE, PPORDER, MMRES, MB21, MB31, MB51, ZPOSTATUS, LT10, LB11, MIGO, ZPPTRF, QA33, COOSPI, Issue to cost center, Customized stock overview(MMBE) and responsible for parent activities of SAP like Resource creation, BOM, recipe and Batch master with finance department, Man hours calculation for manufacturing

Production Deputy Manager

Zydus Cadila Ltd.
Ahmedabad
04.2017 - 01.2019
  • Supervised and trained production team members, ensuring adherence to quality standards and production schedules which mentioned in TTD documents (Technology Transfer plan and Assessment) received from R&D
  • Implemented cost-saving measures resulting in a 10% reduction in production expenses
  • Risk assessment of equipment, procedure, facility & product, Process validation protocol (CQA & CPP), SOP preparation, Requalification of equipments, Qualification study, Change control, Deviation, Investigation protocol, OOS, OOL, CAPA, SOP authorization, Annual calibration matrix, Breakdown report, Impact assessment, Annual training matrix, List of Equipment (LOE) updations, Good Documentation Practice(GDP), Annual Product Quality Review(APQR), Submission of Market authorization dossier for vaccine bulk (Drug Substance),Read & understood Guidelines like Schedule M, WHO-TRS, ICH, PDA, IP, BP, EU, EMEA, HTM(For autoclave), MHRA
  • Collaborated with cross-functional teams to streamline production processes and improve efficiency
  • Responsible for document preparation Technology Transfer Plan & Assessment, Master Formula Record (MFR), Batch Production Records(BPR), Standard Operating Procedures (SOPs), Process Validation (PV) protocols & Record of Results (ROR), Cleaning Validation (CV) Protocols & Record of Results (ROR), Lot Summary Protocol(LSP), Quality Risk Assessment (QRA), Supporting documents Work Experience like OPML & ORML for product code BOM generation
  • Thawing & Formulation: Drug substance of vaccine thawing process & it's subsequent formulation, Calculation of total no of doses
  • Maintained inventory levels and coordinated with vendors to ensure timely delivery of materials for production
  • Requalification & Operation of Vial washing machine, Vial depyrogenation machine, Vial sealing machine, Lyophilizer, Preparation of formulation report of 1 dose, 5 dose, 10 dose of MMR Vaccine - Visual Inspection: Cleaning & Operation of visual inspection booth for Sealed lyophilized and liquid vials, Qualification of visual inspection checkers for lyophilized products, light intensity measurement of visual inspection booth, preparation of standard volume vials of different presentation for different dosage
  • Labeling: PQ of vial labelling machine, Cleaning & operation of vial labelling machine, Line clearance for labeling, coding & packing activity

Production Executive Officer

Serum Institute of India Pvt. Ltd.
Pune
12.2011 - 03.2017
  • Involved in thawing & formulation related activities includes drug substance of vaccine thawing process & it's subsequent formulation, Calculation of total no of doses
  • Responsible for Cell Culture related activities includes Revival of Human Diploid Cell line (MRC-5 Cells), Subsequent passaging in Tissue Culture Flask, Cell Factory & Cell Stack, Medium change, % Viability, Total Cell count, PDL calculation, Preparation of Passaging schedule, BMR, Trypsinization, PBS activity, Cell pool preparation, Mycoplasma & Karyology sampling
  • Executed Media Preparation related activities includes Cell supported Growth Medium(CGM), Cell Maintenance Medium(CMM), Phosphate Buffer Saline, Stabilizers, Trypsin, Trypan blue, SCD broth for aseptic simulation, Production related disinfectant like 70%IPA & other disinfectant solutions, Filter integrity by using BPT & WIT
  • Performed Environmental Monitoring includes Viable & Nonviable monitoring of Grade A, B, C & D (Settle plates, Air sampling, Contact plates & Finger dabs) in daily, weekly & monthly frequency, Gowning Qualification, routine recording of DP, Temp
  • & relative humidity

Education

M.Sc. - Microbiology

M.E.S. Abasaheb Garware College
Pune
07.2011

B.Sc. - Microbiology

D.B.F. Dayanand Arts & Science College
Solapur
06.2009

Skills

  • Supply Chain Management
  • Strategic Sourcing
  • Resource planning
  • Market analysis
  • Manufacturing operations
  • Contract Manufacturing
  • Production Planning
  • Quality Management
  • Technical Operations
  • Problem solving
  • Leadership
  • TrackWise software
  • SAP
  • LIMS
  • DMS
  • LMS tools
  • Project planning
  • Compounding
  • Filling planning
  • Operational Excellence
  • Six Sigma DMAIC
  • Communication
  • Time management
  • Team player
  • Detail-oriented
  • Clear communication

Volunteer Experience

Regular Blood Donor from Year 2006 to present

Hobbies and Interests

  • Exploring distant lands
  • Getting lost in a good book
  • Capturing moments
  • Feeling the music
  • Every kind of sport

Awards

01/01/20, BE Star, Biological E Ltd., Awarded as BE STAR in appreciation of sustained excellence and performance beyond normal expectation in the year 2020.

Personal Information

  • Date of Birth: 03/19/89
  • Nationality: Indian

Affiliations

  • Engage in daily brisk walking, play football with my daughter, and travel extensively across India to explore and appreciate its rich cultural heritage

Accomplishments

  • Awarded as BE STAR in appreciation of sustained excellence
    and performance beyond normal expectation in the year 2020.

Languages

Marathi
First Language
English
Advanced (C1)
C1

Timeline

Lead Sterile Operation, Finished Product Sourcing

Cipla Ltd.
04.2024 - Current

Production Manager

Gland Pharma Ltd.
06.2021 - 04.2024

Production Deputy Manager

Biological E. Ltd.
02.2019 - 05.2021

Production Deputy Manager

Zydus Cadila Ltd.
04.2017 - 01.2019

Production Executive Officer

Serum Institute of India Pvt. Ltd.
12.2011 - 03.2017

M.Sc. - Microbiology

M.E.S. Abasaheb Garware College

B.Sc. - Microbiology

D.B.F. Dayanand Arts & Science College

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Guruprasad Bahiropatil