Ganesh N. Kharche
Thakurli east,MH
Summary
Seeking a position with an esteemed organization where, I can utilize my experience, knowledge & skill for a progressive & bright carrier.
Talented Manager with expert team leadership, planning, and organizational skills built during successful career. Smoothly equip employees to independently handle daily functions and meet customer needs. Diligent trainer and mentor with exceptional management abilities and results-driven approach.
Overview
17
17
years of professional experience
Work History
Manager- CQA
THINQ Pharma (USFDA) (API and Formulation/ LLTP)
04.2021 - Current
- Exposure to handle team and involved in recruitment procedure
- Lead GMP auditor & Actively involved /support during regulatory audits i at manufacturing site/CMOs
- Handling of Vendor/Supplier qualification process and Preparation/Execution of audit schedule
- Conducting Internal audit for plants & External Vendors / Supplier audit for Third party, Loan License business (Domestic as well as International Vendors (China,Germany etc)
- Review of audit compliance report for plant and external vendors. Escalation of critical and Major audit findings to higher management
- Inform to site about recent audit observation and ensure compliance at site
- Also guidance to site for implementation of CAPA
- Expertise in Change Management, Deviation Management /CAPA/OOS/ Customer complaint
- Execution and Review of API artworks
- Conduct training related activity at plant and Corporate office
- Review and Preparation of CQA SOPs
- Involvement in product tech transfer activity from R &D to site
- Handling and implementation on ERP module for Manufacturing unit (Microsoft Nav 2016)
- Review of Vendor /Third party Quality Agreements/CDA
- Review Plant Documents like Process validation,Stability Protocol, APQR,BMR, Specification etc.
Dy. Manager- CQA
THINQ Pharma (USFDA) (API and Formulation/ LLTP)
04.2017 - 03.2021
Senior Executive-Corporate Quality Assurance
USV Pvt. Ltd. (Formulation-USFDA)
09.2015 - 04.2017
- Preparation of Vendor/Supplier audit schedule.
- Conducting Internal & external Vendor/Supplier audits.
- Support the inhouse manufacturing site for the audit of regulatory authority.
- Review and Preparation of CQA SOPs.
- Handling of market complaint.
- Review of Quality Agreements.
- Handling of Change control/Deviation/CAPA.
- Performing role of Department Training Coordinator.
- Preparation of TNID, Conducting Training on CQA SOPs.
- Review of APQR.
Sr. Executive-Quality Assurance
Reliance Life Sciences (Sterile-Formulation)
03.2011 - 09.2015
- Exposure and participated in Internal and External Regulatory/Customers Audits.
- Conducting Manufacturer/Supplier audit and review of compliance.
- Having exposure to handle Electronic system like QAMS (Track wise), LIMS (Lab ware solution), DMS (Pharma Ready), RMS.
- Handling of Deviation, Change Control, CAPA, OOS, and SOPs etc.
- Review and execution of process validation.
- Documents submission to Regulatory for dossier.
- Compilation for Annual Product Quality Review (APQR).
- IPQA checks during formulation, filling and Packing activities.
- Review of Master and Executed BMR/BPR.
- Review of Quality control data for Drug products and Drug Substance.
- QA clearance of Visual inspection activity of PFS & Vials product and controlled areas of manufacturing facility & equipment’s during process.
QC Chemist
Centaur Pharmaceutical Pvt. Ltd. (API-USFDA)
05.2008 - 03.2011
- Sampling & analysis of Raw, Intermediate, Finished product.
- Analysis of stability samples.
- Monitoring and maintenance of control samples of finished products.
- Handling of Instrument and calibration activities like HPLC, Au totitrator, Autokarlfisher, UV, IR, Polarimeter etc.
- Preparation of COAs.
- Participated in Regulatory & Customers Audits.
Education
Master of Science - chemistry
VMU University
Mumbai09.2012
Bachelor of Science - chemistry
Mumbai University
Mumbai03.2008
H.S.C -
Mumbai Board
Mumbai03.2004
S.S.C -
Mumbai Board
Mumbai03.2002
Skills
- Team leadership
- Decision-making
- Time management
- Punctual and hardworking
Accomplishments
- Successfully participated and faced USFDA, EDQM, INVIMA, IMB, Turkey MOH, ISO 9001, OHSAS 18001, ANVISA, WHO, Ukraine, Kazakhstan & Customer audits (P2P) for Drug Substance and Drug Product as a part of Quality team.
- Got Appreciation letter from THINQ management for outstanding performance in year 2019 and year 2023 for work done during USFDA audit.
- Approx 90+ Facility audits (Onsite & Off site/Virtual) (Domestic as well as International (China/Germany)) were conducted for OSD, Sterile facility, Active Drug substance, Key starting materials, Testing laboratories, Primary/Secondary Packaging (Glass bottle, Polybag, Drums) etc.
Languages
English
Hindi
Marathi
Activities
- Attended External Certificate classroom training conducted by pharma consultant Mr. Raghunandan on CAPA/QRM/Investigation and RCA.
- Got (First prize) for certificate of Appreciation in Reliance Life Sciences.
- Completed Certified & Training in Basic life support, First Aid, Fire safety from Usha fire safety equipments (p) ltd.
Passport
Available/ Validity: Feb/2025
(US Visa B1/B2-Oct/2034)
Personal Information
- Date of Birth: 16/Oct/1986
- Marital Status: Married
Timeline
Manager- CQA
THINQ Pharma (USFDA) (API and Formulation/ LLTP)
04.2021 - Current
Dy. Manager- CQA
THINQ Pharma (USFDA) (API and Formulation/ LLTP)
04.2017 - 03.2021
Senior Executive-Corporate Quality Assurance
USV Pvt. Ltd. (Formulation-USFDA)
09.2015 - 04.2017
Sr. Executive-Quality Assurance
Reliance Life Sciences (Sterile-Formulation)
03.2011 - 09.2015
QC Chemist
Centaur Pharmaceutical Pvt. Ltd. (API-USFDA)
05.2008 - 03.2011
Master of Science - chemistry
VMU University
Bachelor of Science - chemistry
Mumbai University
H.S.C -
Mumbai Board
S.S.C -
Mumbai Board
Similar Profiles
Praveen SharmaPraveen Sharma
Stability and QC Compliance Manager at PIRAMAL PHARMA SOLUTION INDORE (Regulatory Approvals: USFDA, MHRA, ANVISA, FIMEA),Stability and QC Compliance Manager at PIRAMAL PHARMA SOLUTION INDORE (Regulatory Approvals: USFDA, MHRA, ANVISA, FIMEA),
Mahesh InamkeMahesh Inamke
Team Lead(Sr.Manager)Analytical Development at THINQ Pharma CROTeam Lead(Sr.Manager)Analytical Development at THINQ Pharma CRO
Hemantkumar JagtapHemantkumar Jagtap
Production Manager at THINQ Pharma CRO Ltd.Production Manager at THINQ Pharma CRO Ltd.