Assistant Manager – QMS & AMV - Biodeal Pharmaceuticals Pvt. Ltd.
(2025-07)
- Managing Quality Management System (QMS) activities within the Quality Control Laboratory.
- Review and approval of SOPs, STPs, GTPs, Specifications, Protocols, Reports, and Quality System documents.
- Leading investigations related to OOS, OOT, Deviations, Laboratory Incidents, and Market Complaints, including root cause analysis and CAPA effectiveness review.
- Performing trend analysis of laboratory investigations and identifying opportunities for continuous improvement.
- Handling Change Control, Risk Assessment, CAPA, and effectiveness verification activities.
- Coordinating and supporting internal audits, self-inspections, and regulatory audit preparedness activities.
- Participating in customer, regulatory, and corporate audits and ensuring timely closure of audit observations.
- Conducting gap assessments against GMP, GLP, Data Integrity, 21 CFR Part 11, and EU Annex 11 requirements.
- Reviewing audit trails, electronic records, and analytical data to ensure Data Integrity compliance.
- Monitoring QMS metrics and preparing monthly quality review reports for management.
- Supporting Analytical Method Validation (AMV), Method Transfer, and Stability Study programs.
- Providing training to QC personnel on QMS procedures, investigation practices, GMP, GLP, and Data Integrity requirements.
- Driving continuous improvement initiatives to strengthen laboratory compliance and inspection readiness.
Senior Executive – Quality Control - Akums Drugs & Pharmaceuticals Ltd.
(2023-07 - 2025-06)
- Reviewing analytical data generated through HPLC, UPLC, GC, UV, and Dissolution systems.
- Managing stability studies and ensuring timely completion of testing activities.
- Reviewing laboratory documentation and ensuring GMP compliance.
- Investigating laboratory deviations, OOS, and OOT results.
- Supporting regulatory and customer audits.
- Training laboratory personnel on GMP, GLP, and Data Integrity practices.
Executive – Quality Control - Abryl Laboratories, Derabassi - Derabassi
(2022-09 - 2023-06)
- Performing analysis of finished products, raw materials, and stability samples.
- Operating HPLC, Dissolution Apparatus, UV Spectrophotometer, and FTIR.
- Preparing analytical reports and maintaining laboratory records.
- Ensuring compliance with approved procedures and specifications.
- Participating in investigation and troubleshooting activities.
Executive – Quality Control - Jubilant Generics Ltd., Roorkee - Roorkee
(2018-02 - 2022-08)
- Conducting analysis of tablets, capsules, oral liquids, and stability samples.
- Performing method execution and routine quality control testing.
- Reviewing analytical results and laboratory documentation.
- Supporting validation and qualification activities.
- Ensuring compliance with GMP, GLP, and Data Integrity requirements.
- Assisting during regulatory inspections and internal audits.
Assistant Executive – Quality Control - Akums Drugs & Pharmaceuticals Ltd.
(2017-04 - 2018-02)
- Analysis of finished products and raw materials.
- Routine operation and maintenance of HPLC, UV, and Dissolution instruments.
- Documentation of analytical activities as per GMP requirements.
- Preparation of laboratory records and test reports.
Officer – Quality Control - Wockhardt Life Sciences Ltd., Baddi - Baddi
(2015-07 - 2017-03)
- Analysis of raw materials, in-process samples, and finished products.
- Execution of wet chemistry and instrumental analysis.
- Calibration and routine verification of laboratory instruments.
- Preparation and maintenance of analytical records.
- Compliance with GMP, GLP, and laboratory safety requirements.
