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Ganesh Kumar Email & Phone Number
Deputy Manager QA
at
Biocon Biologics
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✓ Verified August 2026
3 data sources
Profile completeness 100%
Current company
Role
Deputy Manager QA
Location
Johor Bahru, Johore, Malaysia
Company size
Who is Ganesh Kumar? Overview
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Quick answer
Ganesh Kumar is listed as Deputy Manager QA at Biocon Biologics, a with 5010 employees, based in Johor Bahru, Johore, Malaysia. AeroLeads shows a matched LinkedIn profile for Ganesh Kumar.
Ganesh Kumar previously worked as Deputy Manager production drug substance purification(USFDA) at Biocon and Assistant Manager of Compliance and quality (Computer System Validation(CSV)(USFDA) at Novugen. Ganesh Kumar holds Biomedical Science from Management And Science University.
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Email format at Biocon Biologics
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Biocon Biologics
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Profile bio
About Ganesh Kumar
Pharmaceutical and biopharmaceutical and medical device professional with 10years experience with solid knowledge in Quality, quality control qualification and validation, QMS and (CSV),qualified data integrity trainer,Data integrity champion professional trainer andHandled various audits like USFDA, MHRA,TGA,NPRA and etc.
Listed skills include Leadership, Microsoft Office, Animation, Ultra Performance Liquid Chromatography, and 12 others.
Current workplace
Ganesh Kumar's current company
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Biocon Biologics
9 roles · 16 years
Ganesh Kumar work experience
A career timeline built from the work history available for this profile.
Deputy Manager Production Drug Substance Purification(Usfda)
Current-managing production drug substance-planning and execution - Ensure production compliance
Sep 2023 - Present
Assistant Manager Of Compliance And Quality (Computer System Validation(Csv)(Usfda)
-IT compliance and computer system validation(CSV)-System administrator for EMS,BMS,Testo,SCADA, granulation machine ,EMPOWER 3,Bottle packing machine,roller compactor,blender,FTIR,Vitek and related to production, QC and engineering.-Involved in Computer syatem validation activity for quality control, production and engineering.- Reviewed system audit review for entire QC, production and engineering - Involved in IT infra qualification.-involved in preparation of IT related sops, GAMP5, CSV validation masterplan and -Involve in EQMS implementation
Feb 2022 - Sep 2023
Quality Assurance Assistant Manager(Medical Device)
Oct 2021 - Feb 2022
Assistant Quality Assurance Manager(Qaqc)And Validation
-Involved in computer system validation(CSV) for laboratory-Certificate of analysis (COA) review and approval for exhibit batches.-reviewer and approver of master manufacturing record from R&D.CSV compliance and GAMP 5 in quality control and excel sheet validation review and approval.-Involve Batch Manufacturing Record(BMR) ,Master Manufacturing Formula,Analytical Test Report,Protocol,BOMP and etc.-Internal auditor for plant-Involve in vendor Qualification.-Involve document review for dossier submission and regularity submission(ANDA and NPRA)-Review and approve method validation and method transfer protocols and reports.-review cleaning validation results.-Ensure overall compliance for ANDA submission.-Review and approve inprocess and Finish Product COA.-Involve in regulatory submission document review-Involve batch manufacturing record(BMR) reviewing.-involve in preparation of multimedia dissolution profiling protocol and report.-review hold time study protocol.-involve in vendor qualification audit.-Review and approve specification and STP for quality control.-involve in review IQ OQ and PQ documentation for overall Quality Control.-Prepare protocol and report for reference listed drug versus test drugs(multimedia dissolution profiling).-Ensure analytical method transfer within timeline from analytical development to plant.-check and verify analytical test report in process and finished product.-Involve in API material audit(virtual audit) as auditor.-Ensure quality control compliance and overall compliance.- Direct report to site QA head.-Involve of closure of deviation and out of specification.
Jul 2020 - Oct 2021
Quality Control(Senior Associate/Senior Chemist/Team Lead For Medical Device)
-Involved laboratory CSV validation -Involved in OOS report preparation and deviation report,impact assessment,risk assesment.-Involved medical device testing (insulin pen,cartridges)-involved in internal audit.-Team lead for water testing team.Expertise in using shimadzu TOC as per usp guideline.-Involved in raw material testing report reviewing and vendor qualification for NSM and etc.-Involved in NPRA audit,FDA audit,EMA audit.-Involved in raw material testing and trained analyst for material testing.-Involved in medical device testing and review daily water sampling reports.-Involved in preparing the basalog and mylan pen medical device specification.-Involved in OOS investigation and deviation.-Raw material analytical test report reviewer for water testing and trained new analyst/junior analyst.-Perform instrument calibration for HPLC,UPLC,KARL FISHER,CAD detector,Gas Chromatography,TOC and etc.-Involved in thermal mapping activity.-Involved in commissioning and qualification of laboratory instruments.-Involved in preparing URS,DQ,I,OQ and PQ protocol and reports.-Trained analyst on troubleshooting and instrument calibration.-Involved in preventive maintenance activity with liase maintenance team.
Jul 2019 - Jul 2020
Quality Control Associate(In Process) And Analytical Support Ast For Injectable
-Qualified analytical and technical specialist from MOPE- Involve in computer system validation(CSV) for quality control empower software validation.-Involved in method transfer and method validation for Human Insulin,Aspart and Glargine.-Able to handle and perform HPLC,UPLC,TOC,GC.-Involved in bio-pharmaceutical commissioning untill product release to the market.-Involved in URS, Design qualification,installation Qualification and performance qualification for analytical instruments. -Able to handle troubleshooting for HPLC,UPLC,FTIR GC,TOC and etc-Performing calibration of the instruments.-Qualifiying analytical column and working standards.
Nov 2013 - Jul 2019
Executive
Dec 2012 - Oct 2013
Executive
2011 - 2012
~1 yr
1 education record
Ganesh Kumar education
FAQ
Frequently asked questions about Ganesh Kumar
Quick answers generated from the profile data available on this page.
What company does Ganesh Kumar work for?
Ganesh Kumar works for Biocon Biologics.
What is Ganesh Kumar's role at Biocon Biologics?
Ganesh Kumar is listed as Deputy Manager QA at Biocon Biologics.
Where is Ganesh Kumar based?
Ganesh Kumar is based in Johor Bahru, Johore, Malaysia while working with Biocon Biologics.
What companies has Ganesh Kumar worked for?
Ganesh Kumar has worked for Biocon Biologics, Biocon, Novugen, Dksh, and Novugen Pharma (Malaysia) Sdn. Bhd..
How can I contact Ganesh Kumar?
You can use AeroLeads to view verified contact signals for Ganesh Kumar at Biocon Biologics, including work email, phone, and LinkedIn data when available.
What schools did Ganesh Kumar attend?
Ganesh Kumar holds Biomedical Science from Management And Science University.
What skills is Ganesh Kumar known for?
Ganesh Kumar is listed with skills including Leadership, Microsoft Office, Animation, Ultra Performance Liquid Chromatography, Research, Marketing, Good Laboratory Practice, and Laboratory Skills.
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