Senthil Kumar T M
Bangalore
Summary
Quality professional with 34 years of experience in handling API and formulations, CMO sites, QMS implementation, cGMP compliance, audit and CAPA compliance, GMP training, customer/regulatory audits. Experienced with SAP system and TrackWise applications. Completed the service period successfully and retired from service in 2025.
Overview
34
34
years of professional experience
1991
1991
years of post-secondary education
Work History
Senior Manager- CQA
M/s Biocon Ltd.
08.2008 - 05.2025
- Handling of CMO sites - API and Formulations. Handled more than 30 CMO sites of domestic and international locations including China, UK and US.
- Handling of corporate Supplier Management - API and formulations
- CMO site/Supplier site audits, approval and ensure GMP/QMS compliance.
- Review and execution of CMO/Supplier site Quality Agreements and ensure compliance.
- Handling of QMS and CMO sites/supplier sites Qualification in track-wise application.
- Periodical Monitoring and control of CMO sites/ Supplier sites Quality Performance.
- Experience in USFDA, EUGMP, IMB and French health Authority, TGA and MHRA, Mexican Authority, Korean Health Authority and Health Canada Authority audits.
QA Manager
M/s Kemwell Pvt. Ltd.
01.2006 - 01.2008
- Experience in QMS system implementation and QA functions, CMO/Supplier audits, Scheduling and organizing all Validation programs in the site, Scheduling, Organizing and Conducting Training programme for employees, Training and Validation Documentation, Handling of International and Local Audits.
- International Audits Handled- GSK, UK, Johnson and Johnson-US, Bayer - Germany and US FDA consultancy audit.
Training Manager
M/s Remidex Pharma Pvt. Ltd.
01.2000 - 01.2006
- Experience in QA Activities including preparation of master documents, Scheduling and Organising all Validation programmes in the site, Scheduling, organising and Conducting Training programme for employees, Training and validation Documentation and Handling of International and Local Audits.
- International Audits Handled- NDA, Uganda Lundbeck, Denmark, FDA, Tanzania, GSKCH, Mexico, GSK, Australia and HSA, Singapore.
Pharma Manager
M/s CIPLA Ltd.
01.1999 - 01.2000
- Experience in handling of the following formulation planning - Production / Export as per schedule & meeting dispatch schedules, Planning Raw / Packing materials, Staffing, In process / Rejection Control, Documentation Control, Training on CGMP, Safety, Cleanliness, Health & Hygiene, Entry Procedures and Review and updating SOP's.
- Handling of International audits- MCA, TGA and US FDA.
Deputy Production Manager
M/s Global Parentarals Pvt. Ltd.
01.1995 - 01.1998
- Exposure Planning - Production / Export as per schedule & meeting despatch schedules, Planning Raw / Packing materials, Staffing, In process / Rejection Control Documentation Control, Review and updating SOP's, Training of working personnel on CGMP, Sterile area operating Procedures, Entry Procedures, Health and Hygiene etc.
- Validation of Equipment including Sterilizers (DQ, OQ, IQ, PQ), HVAC system in Sterile Area, Process by process simulation studies (Broth Filling Trial), Visual inspectors and Sterile Area working personnel.
- Handling of International Audits -Glaxo UK, Pfizer US and Rhone Phoulic, US.
Manufacturing Chemist
M/s American Remidies Ltd.
01.1991 - 01.1995
- Experience in handling of the following formulation Tablets, Capsules and Liquid Orals.
- Complete Exposure in Manufacturing and Packing of formulations mentioned above' Achieving day to day production target as per planning schedule, Maintaining Quality system as per written down procedure, Control on rejection rate by maintaining machineries in good working conditions and Achieving good production yield.
Education
Bachelor of Pharmacy (B.Pharm) -
JSS Institute, Mysore University
Mysore, KarnatakaSkills
Quality management System
Technical Skills Training
- Certification/ training for Lead Auditor and GMP auditor
- QMS and Risk management training
- ICH Q7 and Q10 training
Awards
Quality First achievement Award in Biocon ltd.
Additional Qualifications
- MBA in Pharma Management, Pharma - Management principles, Supply chain management, Marketing and Regulatory compliance
- Diploma in Bio informatics, Global Infotech, Bangalore, Molecular biology, Core Bio-informatics, Genomics, Proteomics, Molecular modeling, Drug designing and bio computing.
- Diploma in Computer Applications
Timeline
Senior Manager- CQA
M/s Biocon Ltd.
08.2008 - 05.2025
QA Manager
M/s Kemwell Pvt. Ltd.
01.2006 - 01.2008
Training Manager
M/s Remidex Pharma Pvt. Ltd.
01.2000 - 01.2006
Pharma Manager
M/s CIPLA Ltd.
01.1999 - 01.2000
Deputy Production Manager
M/s Global Parentarals Pvt. Ltd.
01.1995 - 01.1998
Manufacturing Chemist
M/s American Remidies Ltd.
01.1991 - 01.1995
Bachelor of Pharmacy (B.Pharm) -
JSS Institute, Mysore University
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