Debtanu Chaudhuri
Bangalore
Summary
Energetic professional with 14 years of experience in industry. Punctual employee dedicated to following Quality environment to Quality mishaps. Considered valuable and hardworking employee by supervisors and peers.
Overview
14
14
years of professional experience
Work History
Sr. Team Lead (Site QA Lead)
Stelis Biopharma Ltd.
Bangalore
2021.08 - Current
- Leading the Site QA Operations, Process Assurance, CQV, CSV, QMS, Technical Writing, Audit & Compliance.
Deputy Manager
Hyde Engineering & Consulting
Bangalore
2021.02 - 2021.07
- Involved in CQV activity for HVAC and Utilities in Oncogen Pharma (Malaysia).
Deputy Manager-QA Engineering
Biocon Bologics Ltd.
Bangalore
2017.03 - 2021.01
- Involved in CQV activities 2 Greenfield and 1 Brownfield Projects for CQV activities for HVAC, Black & Clean Utilities, Process Equipment.
Management Staff-QA Validation
Cipla BioTec Ltd.
Goa
2015.12 - 2017.02
- Involved in validation activities, QMS, Involved in 1 Brownfield Project for CQV activities of Clean Utilities and HVAC.
Executive- QA
Wockhardt Biotech ltd.
Aurangabad
2012.12 - 2015.12
- Involved in Process Assurance, QMS, Documentation.
- Involved in 1 Brownfield Project for CQV activity of Clean Activities.
Jr. Manager
Dr. Reddy's Lab
Hyderabad
2010.09 - 2012.11
- Involved in Manufacturing Activities of Synthetic API, QMS, Documentation.
Technical Trainee-QA
Cipla Ltd.
Rangpo, Sikkim
2010.03 - 2010.08
- Technical Trainee in IPQA.
Education
MBA - Quality Management System
Master of Business Administration
2016-08
Master of Science - Biotechnology
Master of Technology
2008-08
Skills
- Quality Assurance,
- Drug Substance.
- Team Management
- CQV/CSV/Validation.
- Technology Transfer.
- QMS, Technical Writing, Documentation.
- Audit and Compliance,
- EMA/USFDA/MHRA/CDSCO
- eDMS/Trackwise/eValgenesis
- Coaching and Mentoring
- Stakeholder Management
- Production Coordination
- Work Planning
- Problem-Solving
- Leadership
Timeline
Sr. Team Lead (Site QA Lead)
Stelis Biopharma Ltd.
2021.08 - Current
Deputy Manager
Hyde Engineering & Consulting
2021.02 - 2021.07
Deputy Manager-QA Engineering
Biocon Bologics Ltd.
2017.03 - 2021.01
Management Staff-QA Validation
Cipla BioTec Ltd.
2015.12 - 2017.02
Executive- QA
Wockhardt Biotech ltd.
2012.12 - 2015.12
Jr. Manager
Dr. Reddy's Lab
2010.09 - 2012.11
Technical Trainee-QA
Cipla Ltd.
2010.03 - 2010.08
MBA - Quality Management System
Master of Business Administration
Master of Science - Biotechnology
Master of Technology
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