Hi, I’m
Manoj Kumar
Sultanpur,Uttar Pradesh
Summary
Dedicated pharmaceutical quality professional with over a decade of experience, seeking to leverage expertise in ensuring regulatory compliance, process optimization, and product excellence. Committed to upholding the highest standards of quality and safety in the industry.
Overview
13
years of professional experience
1
Certification
Work History
Pfizer Health care India Pvt LtdVisakhapattnam
Associate Manager-Quality
12.2021 - Current
Job overview
- Change Management
- Quality Risk Management
- CAPA management
- Trained Quality Trainer
- Quality review & approval for procedure, Qualification/ study protocol/ reports etc
Pfizer Health care India Pvt LtdVisakhapattnam
Sr. Associate-Manufacturing Quality
08.2015 - 12.2021
Job overview
- Work order assessment,
- Exception assessment & closure
- Audit trail review
- Area walkthrough & Quality oversight
Fresenius Kabi Oncology LimitedBaddi
Sr. Officer Quality
03.2014 - 07.2015
Job overview
- Batch record Preparation & Review
- Change management, Market Complaint
- Document Management
- Investigation
- Trained Trainer
Nectar Lifesciences Ltd., Unit VIBaddi
Sr. Officer-QA
09.2012 - 03.2014
Job overview
- Supplier Qualification
- Packing material & BOM review/ Approval
- Document management
Osper FormulationsBaddi
Trainee QA Executive
07.2009 - 11.2010
Job overview
- In-process Quality, Walkthrough & Sampling
- Reviewer of batch records
Education
Rajiv Gandhi Proudyogiki Vishwavidyalaya, Bhopal (MP)
M.Pharm from Pharmaceutical Sciences
06.2012
Uttar Pradesh Technical University , Lucknow
B.Pharm from Pharmaceutical Sciences
06.2009
Skills
Change management,
Market Complaint
Investigation
Document Management
Trained Trainer
Batch record Preparation & Review
Supplier Qualification
Effective Quality reviewer
Languages
Hindi
First Language
English
Proficient
C2
Accomplishments
- I was the part of many Continuous projects for compliance, Quality & financial benefits to organization like Parallel In-process, Change request duplication, Reduction of change action extension, Effective Document review to avoid PHP reduction, Hot flush removal etc.
- I am confident that should I be given a chance to prove myself, I will leave upto expectation.
Certification
- Certified Lead QMS Auditor from Udemy in Aug 2023
- Six Sigma Black Belt from XLNC Academy in Apr 2023
- Leadership Foundations: Leadership Styles and Models - LinkedIn in Jun 2023
- Critical Thinking & Decision making from Project Management Institute in Jul 2023
- Project Management Foundations: Quality from Project Management Institute in Aug 2023
Timeline
Associate Manager-Quality
Pfizer Health care India Pvt Ltd
12.2021 - Current
Sr. Associate-Manufacturing Quality
Pfizer Health care India Pvt Ltd
08.2015 - 12.2021
Sr. Officer Quality
Fresenius Kabi Oncology Limited
03.2014 - 07.2015
Sr. Officer-QA
Nectar Lifesciences Ltd., Unit VI
09.2012 - 03.2014
Trainee QA Executive
Osper Formulations
07.2009 - 11.2010
Rajiv Gandhi Proudyogiki Vishwavidyalaya
M.Pharm from Pharmaceutical Sciences
Uttar Pradesh Technical University
B.Pharm from Pharmaceutical Sciences
- Certified Lead QMS Auditor from Udemy in Aug 2023
- Six Sigma Black Belt from XLNC Academy in Apr 2023
- Leadership Foundations: Leadership Styles and Models - LinkedIn in Jun 2023
- Critical Thinking & Decision making from Project Management Institute in Jul 2023
- Project Management Foundations: Quality from Project Management Institute in Aug 2023
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