Jean Vinodh Kumar
Puducherry
Summary
Jean VINODH KUMAR.K (Sr. Executive –Quality control), with over 17 years of experience in pharmaceutical quality control department, highly energetic professional who has sharpened my problem-solving skills and attention to detail in a consent decree environment. Rich experience of handling regulatory and internal audits as a SME. Having exposure on ISO-9001,ISO-14001,ISO-27001, OHSAS-18001,USFDA,MHRA,EDQM, WHO GMP, COFEPRIS, TGA.
Overview
17
17
years of professional experience
1
1
Certification
Work History
Senior-Executive Quality Control
SUN PHARMACEUTICAL INDUSTRIES LTD
2014.03 - Current
- Performing sampling analysis and reporting of Raw materials, Packing materials, Finished Products, intermediates, in-process ,stability sample and routine analysis
- Reference standard and working standard managements
- Qualification of in-house working standards
- Performing analyst qualification
- Engaged in stability, hold time study of samples and preparing stability summary reports
- Reporting lab incidents, OOS, OOT or any deviations observed in laboratory
- Initiation and review of OOS, OOT, lab events through Track wise
- Ensuring compliance with regulatory requirements by maintain accurate records and documents
- Working with cross-functional teams to resolve quality issues and implementing corrective actions
- Review of audit trails of analytical instruments engaged in the laboratory
- Audit trail review of analytical instruments engaged in the laboratory
- Monitoring data integrity and laboratory compliance in the quality control department
- Review of Finished Products, Raw materials, in-process, intermediates sample in LIMS and preparing COAs
- Performing Analytical method transfer and verification.
STERIL-GENE LIFE SCIENCES PVT LTD, FORMULATION UNIT
2013.01 - 2014.02
Executive- Quality Control
SHASUN PHARMACEUTICALS LTD, API UNIT-I
2007.03 - 2013.01
- Analysis of Raw materials, Packing materials, In-process and Finished Products and preparing Analytical test reports through SAP
- Engaged in Instrumental analysis like HPLC, GC, LCMS, GC-HS, IR,UV, SOR, Malvern Particle Size Analyzer
- Calibration of analytical instruments and maintaining calibration schedule records
- Preparation of Raw materials and finished product specification as per pharmacopeia
- Conducting stability study as per protocol
- Handling the investigation of OOS/OOT, Lab events
- Checking calibration due of all analytical instruments, log books, Validity of standards, chemicals, reagents and stock solution on daily basis.
Education
MPhil. Chemistry -
Vinayaka Missions University
01.2009
MSc.Chemistry -
Annamalai University
01.2006
Bsc.Chemistry -
Tagore Arts College
01.2004
Skills
- Operations Management
- Report Preparation
- Cross-functional Team Coordination
- Staff Management
- Performance Improvement
- Technical Support
- Scheduling
- Teamwork and Collaboration
- Problem-Solving
- Time Management
- Decision-Making
- Documentation And Reporting
- Analytical Thinking
Certification
- ADVANCED POST GRADUATE DIPLOMA IN COMPUTER APPLICATIONS ( Oracle, MS- Office, VB, C,C++)
- Successfully completed course on “Ensuring Laboratory Data Integrity:QC-L-1-I-B1” conducted by Technical Training Academy, Sun Pharmaceuticals Industries Limited, Vadodara.
Languages
English
Hindi
Tamil
Malayalam
Handlinginstruments
- HPLC WATERS ALLIANCE e2695 with 2998 PDA DETECTOR
- HPLC WATERS ALLIANCE e2695 with 2489 UV/VIS DETECTOR
- SHIMADZU GC 2010 PLUS with AOC 20I, HS-20
- SHIMADZU GC2010 with AOC-20I and AOC-20S
- SHIMADZU GC-2014 with AOC-5000
- ACQUITY TM UPLC with TUV DETECTOR, Binary solvent Manager
- ACQUITY TM UPLC , Quaternary Solvent Manager
- UV/VIS Spectrophotometer , UV-1800,UV-2600 with Lab solution
- IR PRESTIGE-21,IR TRACER-100 with Lab solution
Personal Information
- Father's Name: Krishnan Unni. V
- Date of Birth: 12/01/83
- Nationality: Indian
- Marital Status: Married
Disclaimer
I here by confirm that above information give in the form is true to the best of my knowledge and belief.
Timeline
Senior-Executive Quality Control
SUN PHARMACEUTICAL INDUSTRIES LTD
2014.03 - Current
STERIL-GENE LIFE SCIENCES PVT LTD, FORMULATION UNIT
2013.01 - 2014.02
Executive- Quality Control
SHASUN PHARMACEUTICALS LTD, API UNIT-I
2007.03 - 2013.01
MPhil. Chemistry -
Vinayaka Missions University
MSc.Chemistry -
Annamalai University
Bsc.Chemistry -
Tagore Arts College
- ADVANCED POST GRADUATE DIPLOMA IN COMPUTER APPLICATIONS ( Oracle, MS- Office, VB, C,C++)
- Successfully completed course on “Ensuring Laboratory Data Integrity:QC-L-1-I-B1” conducted by Technical Training Academy, Sun Pharmaceuticals Industries Limited, Vadodara.
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