Suhas Donti
Myself Suhas Kumar DS, working as a Deputy Manager in Quality Control department for Kemwell Biopharma. I am... | Bangalore Urban, Karnataka, India
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Suhas Donti’s Emails su****@sy****.com
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Suhas Donti’s Location Bangalore Urban, Karnataka, India
Suhas Donti’s Expertise Myself Suhas Kumar DS, working as a Deputy Manager in Quality Control department for Kemwell Biopharma. I am a qualified biotech professional having 10.5 years of experience in Quality Control-Biologics and Quality Management System operations in Biotech Industry. Currently I am leading Stability management and Compliance section. Here are my few accomplishments of 10.5 years of work experience: 1. Planning of stability testing and for reporting and trending of stability data. 2. Communicating with regulatory and updating dossier tasks. 3. Coordination with clients and cross functional teams for planning stability strategy. 4. Playing active participations in regulatory preparations and audits. 5. Review and approval of generated technical documentation. 6. Retention and reference sample management 7. Lead investigator for handling of major and minor deviations. 8. Leading OOS and OOT investigations. 9. Handling of Change management system & Risk assessment 10. Audit trail review to check data integrity. 11. Analytical method transfer and method validation for Biosimilars. 12. Failure Investigation/Root cause analysis using various analytical techniques. 13. Implementation of LIMS to QC laboratory from URS (User requirement specification) preparation to Go Live in production server. 14. Qualification of working standards against Innovators. 15. Documentation as per GMP practice. 16. Preparation of specifications and Standard Testing Procedures. 17. Effective GMP trainer. 18. Equipment qualifications. 19. Identification of required document change. 20. Work with fellow team members with in the department and cross functional teams on departmental initiatives. 21. Tracking of QMS documents and make sure document closures with in the targeted time line.
Suhas Donti’s Current Industry Alvotech
Suhas
Donti’s Prior Industry
National Institute For Research In Tuberculosis
|
Biocon
|
Reliance Life Sciences
|
Syngene International
|
Kemwell Biopharma
|
Alvotech
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Work Experience
Alvotech
Principal Compliance Specialist
Tue Mar 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Present
Alvotech
Senior Specialist Quality Compliance
Sat Jan 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Mar 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time)
Kemwell Biopharma
Deputy Manager
Sun Sep 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Jan 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time)
Kemwell Biopharma
Assistant Manager
Sat Oct 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun Sep 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time)
Syngene International
Senior Executive
Mon Jun 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Oct 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time)
Reliance Life Sciences
Quality Control
Mon Sep 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Jun 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time)
Biocon
Executive
Sun Jan 01 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Sep 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time)
National Institute For Research In Tuberculosis
Research Trainee
Thu Jul 01 2010 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Dec 01 2011 00:00:00 GMT+0000 (Coordinated Universal Time)Skills
Languages
Suhas Donti Email Addresses
FAQ About Suhas Donti
-
Suhas Donti is located at
Bangalore Urban, Karnataka, India -
Suhas Donti is a
Myself Suhas Kumar DS, working as a Deputy Manager in Quality Control department for Kemwell Biopharma. I am a qualified biotech professional having 10.5 years of experience in Quality Control-Biologics and Quality Management System operations in Biotech Industry. Currently I am leading Stability management and Compliance section. Here are my few accomplishments of 10.5 years of work experience: 1. Planning of stability testing and for reporting and trending of stability data. 2. Communicating with regulatory and updating dossier tasks. 3. Coordination with clients and cross functional teams for planning stability strategy. 4. Playing active participations in regulatory preparations and audits. 5. Review and approval of generated technical documentation. 6. Retention and reference sample management 7. Lead investigator for handling of major and minor deviations. 8. Leading OOS and OOT investigations. 9. Handling of Change management system & Risk assessment 10. Audit trail review to check data integrity. 11. Analytical method transfer and method validation for Biosimilars. 12. Failure Investigation/Root cause analysis using various analytical techniques. 13. Implementation of LIMS to QC laboratory from URS (User requirement specification) preparation to Go Live in production server. 14. Qualification of working standards against Innovators. 15. Documentation as per GMP practice. 16. Preparation of specifications and Standard Testing Procedures. 17. Effective GMP trainer. 18. Equipment qualifications. 19. Identification of required document change. 20. Work with fellow team members with in the department and cross functional teams on departmental initiatives. 21. Tracking of QMS documents and make sure document closures with in the targeted time line. Alvotech -
Suhas Donti currently works in the
Alvotech -
Suhas Donti specializes in
Myself Suhas Kumar DS, working as a Deputy Manager in Quality Control department for Kemwell Biopharma. I am a qualified biotech professional having 10.5 years of experience in Quality Control-Biologics and Quality Management System operations in Biotech Industry. Currently I am leading Stability management and Compliance section. Here are my few accomplishments of 10.5 years of work experience: 1. Planning of stability testing and for reporting and trending of stability data. 2. Communicating with regulatory and updating dossier tasks. 3. Coordination with clients and cross functional teams for planning stability strategy. 4. Playing active participations in regulatory preparations and audits. 5. Review and approval of generated technical documentation. 6. Retention and reference sample management 7. Lead investigator for handling of major and minor deviations. 8. Leading OOS and OOT investigations. 9. Handling of Change management system & Risk assessment 10. Audit trail review to check data integrity. 11. Analytical method transfer and method validation for Biosimilars. 12. Failure Investigation/Root cause analysis using various analytical techniques. 13. Implementation of LIMS to QC laboratory from URS (User requirement specification) preparation to Go Live in production server. 14. Qualification of working standards against Innovators. 15. Documentation as per GMP practice. 16. Preparation of specifications and Standard Testing Procedures. 17. Effective GMP trainer. 18. Equipment qualifications. 19. Identification of required document change. 20. Work with fellow team members with in the department and cross functional teams on departmental initiatives. 21. Tracking of QMS documents and make sure document closures with in the targeted time line. -
Suhas Donti speaks the following languages:
No languages available. -
Suhas Donti has prior experience in the following industries:
Alvotech , Kemwell Biopharma , Kemwell Biopharma , Syngene International , Reliance Life Sciences , Biocon , National Institute For Research In Tuberculosis -
Suhas Donti has the following professional experience:
Alvotech , Alvotech , Kemwell Biopharma , Kemwell Biopharma , Syngene International , Reliance Life Sciences , Biocon , National Institute For Research In Tuberculosis . -
You can view Suhas Donti’s
LinkedIn profile at LinkedIn URL. -
Suhas Donti’s work email addresses are
[email protected] . -
Suhas Donti works at
Alvotech
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