BAJARANG WAGH
Mumbai
Summary
MSc Organic Chemistry with 20 years of diverse experience in Analytical Development and Quality Control Operations for different regulatory markets. QC Governance of Contract manufacturing operation. Handled the variety of formulations and markets on Analytical Specification and Method development & transfer activity. FDA approved chemist in Chemical analysis and Instrumentation from Indian FDA. ISO 9001:2015 Lead Auditor in Quality Management Systems from IRCLASS accredited by IRCA & CQI. Ready to bring technical and operational skill in management of Quality control laboratory and provide analytical skill.
Overview
21
21
years of professional experience
Work History
Freelancer
GXP Consultants
10.2024 - Current
- GMP Quality Auditor to Conduct Audits in India and China
- GMP Quality Supports to Pharma Companies
MANAGER QUALITY
Sanofi India Ltd
04.2023 - 08.2024
- QC Due Diligence for Contract manufacturing Facility and third-party lab.
- Quality Control Governance of Contract manufacturing testing laboratory.
- Analytical method transfers to CMO from R&D Site to CMO site.
- Nitrosamine compliance, risk assessment and testing for DP.
- Quality Agreements and Oversite of CMO
- OOS Investigations and root cause analysis at CMO site.
- Monitored compliance with industry regulations and organizational policies.
MANAGER, ANALYTICAL DEVELOPMENT
Sanofi India Ltd
07.2008 - 03.2023
- Leading a team for Analytical and Quality operation activities
- Review and decision making on status of all the Analytical Method Development (FDC), Validation and Transfers
- Troubleshooting & training of analytical instruments like HPLC, GC, Dissolution testers
- Management of Stability studies, Retention Sample Room, Incubators and Procurement of reference standards
- Management of working standards
- Conducted performance evaluations, providing constructive feedback to team members.
Sr. Executive-Quality Control
Dr. Reddy’s Laboratories
09.2006 - 07.2008
- Audit Readiness for Quality control dept.
- Stability studies management and trending.
- Management of Working Standards, Impurity standards & Reference standards
- Analysis and data review of RM, PM, DP, DS and Stability Studies.
- Calibration management of analytical instruments.
Quality Control-Officer
Lupin LTD
05.2005 - 08.2006
- Sampling of RM/PM
- Performance Verification of various instruments
- Testing and Release of In process/Finished Product
- Stability Chambers and Stability studies management.
Education
M.Sc. - Organic Chemistry
Shivaji University
Kolhapur06-2004
B.Sc. - Organic Chemistry
Shivaji Uni
Kolhapur06-2002
Skills
- QC Operation
- Team Management
- Analytica method dev
- HPLC
- GC
- Mass
- IR
- Trouble Shooting
- Nitrosamine testing
- Technical proficiency
- Work Planning and Prioritization
Timeline
Freelancer
GXP Consultants
10.2024 - Current
MANAGER QUALITY
Sanofi India Ltd
04.2023 - 08.2024
MANAGER, ANALYTICAL DEVELOPMENT
Sanofi India Ltd
07.2008 - 03.2023
Sr. Executive-Quality Control
Dr. Reddy’s Laboratories
09.2006 - 07.2008
Quality Control-Officer
Lupin LTD
05.2005 - 08.2006
M.Sc. - Organic Chemistry
Shivaji University
B.Sc. - Organic Chemistry
Shivaji Uni
Scale Of Experience
> 25 CMO Laboratory, ~ 75 Supplier Audits, + Variety of Formulations, > 10 people, in Chemical analysis and Instrumentation from Indian FDA, ISO 9001:2015 Lead Auditor from IRCLASS accredited by IRCA & CQI
Personal Information
Title: Quality Control & Analytical Development