Dinesh Kumar
Sr. Manager - Quality Assurace
Bengaluru
Summary
Quality Assurance professional with over 16 years of experience in pharmaceutical injectables and regulatory compliance across multiple global agencies including USFDA, EMA, and WHO. Proven expertise in conducting audits, managing market complaints, and implementing Quality Management Systems (QMS). Skilled in risk management and quality review processes, with a strong track record of successful remediation efforts. Committed to maintaining high standards of quality and compliance in all operational aspects.
Overview
17
17
years of professional experience
1
1
Certification
Work History
Senior Group Leader
Viatris
Benguluru
2016.04 - Current
- Lead Audit and Compliance - Handling Internal Audits, Global Audits, Regulatory Audits and other inspection from Business Partners and Customers. Handling response preparations and CAPA follow-ups to uphold audit findings.
Lead Quality Risk Management.
Supervised complaint management from logging through closure to ensure resolution.
Administered QMS tasks such as investigations, CAPA, and change control effectively.
Oversaw Batch release activity, Coordinated with production and QA teams for timely product release across markets.
Supervised Product Quality Review Activities (APQR and CPV).
Maintained strict adherence to SOPs and upheld USFDA/cGMP compliance in documentation practices.
Monitor quality metrics and implement continuous improvement initiatives across departments.
Quality compliance, IPQA, Quality KPI oversight.
Led implementation of quality harmonization projects while conducting industry-standard gap assessments.
Associate Scientist- Development QA (IPQA and QMS)
Shantha Biotec (Sanofi)
Hyderabad
2014.07 - 2016.04
- Lead QMS (Change Control, Deviations, OOS, CAPA, Failure Investigation) and regulatory audit coordination/response.
Ensure cGMP Batch Release compliance, manage all Quality Documentation.
Oversee and execute validation studies (Process, Cleaning, Analytical Method), including Protocol/Report review and IPQA activities.
Manage Quality governance activities: Risk Management, stability studies, Cell Bank Management, regulatory submission support, and training coordination.
Senior Officer QA (Documentation and Validation)
Ranbaxy
Bangalore
2013.09 - 2014.06
- Handled Quality Management System (QMS), encompassing Batch Release compliance, Change Control, Deviations, OOS, Investigations, and CAPA.
Maintain rigorous Quality Documents control, managed regulatory submissions support, and ensure training program coordination.
Plan and execute all required validation studies (Process/Cleaning), and oversee stability and Cell Bank Management programs.
Support internal and regulatory Audits, review of utility and environmental monitoring trends.
Sr. Scientific Officer QA (Batch Release /Document
Panacea Biotec
Chandigarh
2009.10 - 2013.08
- Handled Batch Release and QMS (OOS, Change Control, Deviations, CAPA).
Managed Documentation (SOPs, BMRs, Periodic Review) .
Oversee and execute Operational Quality (IPQA, Line Clearance, Data Review, SAP activities) and support Process Validation/Technology Transfer.
Responsible for Quality Governance elements including Self-Inspection, Annual Product Review (APR/PQR), Stability/Shelf Life assignment, and Cell Bank Management.
Quality Analyst (QA -IPQA and Documentation)
Bakson Drugs and Pharmaceutical Pvt. Limited
Solan
2008.12 - 2009.10
- Execute and monitor Operational Quality (IPQA, Line Clearance, Process Checks for various dosage forms).
Support for Stability Review, Control and maintain all Documentation by preparing/reviewing SOPs, BMRs, Lot Records, and performing data review.
Education
Master of Science - Biotechnology
Bangalore University
Bangalore2008-06
Bachelor of Science - Chemistry
Himachal Pradesh University Shimla
Shimla2006-03
Skills
- Audit Management
- Quality Management Systems (Investigations, Change Controls and CAPA)
- Quality Risk Management
- Complaint Handling
- Batch Release Oversight
- Quality Compliance
- Gap Assessments
- Quality Metrics
- GMP Documentation
- APQR and CPV
- Continuous improvement
- Team management
Languages
English
Proficient (C2)
C2
Hindi
Proficient (C2)
C2
kannada
Beginner
A1
Certification
Cerified Quality Analyst by State FDA
Affiliations
ISPE Conference at Mumbai
Timeline
Senior Group Leader
Viatris
2016.04 - Current
Associate Scientist- Development QA (IPQA and QMS)
Shantha Biotec (Sanofi)
2014.07 - 2016.04
Senior Officer QA (Documentation and Validation)
Ranbaxy
2013.09 - 2014.06
Sr. Scientific Officer QA (Batch Release /Document
Panacea Biotec
2009.10 - 2013.08
Quality Analyst (QA -IPQA and Documentation)
Bakson Drugs and Pharmaceutical Pvt. Limited
2008.12 - 2009.10
Master of Science - Biotechnology
Bangalore University
Bachelor of Science - Chemistry
Himachal Pradesh University Shimla