Quality Control leader with 27 years of experience in pharmaceutical manufacturing. Expertise in API, raw materials, stability studies, and regulatory compliance, with exposure to global audits by US FDA, WHO, ISO, PMDA, and COFEPRIS. Skilled in laboratory operations, method validation, and cross-functional coordination, driving quality and compliance in high-stakes environments.
Overview
1
1
Language
27
27
years of professional experience
4
4
Certificates
Work History
Senior Team Leader – Quality Control
Dr. Reddy’s Laboratories Ltd.
03.1999 - 03.2026
Lead quality control operations for raw materials, in-process samples, intermediates, and finished products.
Ensure timely testing and release/rejection decisions based on specifications.
Conduct and oversee OOS, OOT, and lab incident, or deviation investigations.
Maintain strict adherence to GLP, SOPs, and regulatory requirements.
Drive cross-functional coordination with R&D, production, RA, QA, and external labs.
Prepare and review daily/monthly QC reports, Certificates of Analysis, and compliance documentation to ensure regulatory adherence.
Led UV method validation and recovery factor studies across plant products, ensuring compliance with quality standards, and improving product reliability.
Played a key role in successful regulatory audits (U.S. FDA, WHO, ISO, EDQM, PMDA, COFEPRIS).
Manage instrument calibration's and preventive maintenance schedules.
Strengthened documentation practices by implementing error-free online documentation systems, enhancing accuracy, and accessibility.
Demonstrated leadership by guiding teams in quality initiatives.
*Previous Role Progression (Internal Growth)*
Assistant Manager – Managed API, RM, regulatory, dispatches, marketing samples, and CoA activities.
Junior Manager – Focused on finished product analysis, regulatory testing, and stability studies.
Senior Executive – Handled calibrations, working standards, and advanced instrumentation (GC, HPLC, XRD).
Executive – Managed in-process analysis and validation activities.
Senior Officer - Quality/Quality Control Team Leader at Enerlife India Pvt LtdSenior Officer - Quality/Quality Control Team Leader at Enerlife India Pvt Ltd