Executive CQA - Crescent Pharma UK (India Office)
(2025-12)
- Managing Quality Management System (QMS) activities for 10 Contract Manufacturing Organization (CMO) sites.
- Handling Change Controls and Deviations through QMS software (Master Control), ensuring compliance with regulatory and internal quality requirements.
- Reviewing Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR) of finished products to ensure accuracy, completeness, and compliance.
- Tracking and monitoring Corrective and Preventive Actions (CAPA) across CMO sites to ensure timely closure and effectiveness.
- Reviewing risk and impact assessments and ensuring effective risk communication in accordance with quality risk management principles.
- Site Audit of CMO site.
Senior Executive CQA - Naprod Life Sciences Pvt. Ltd - Boisar, Palghar
(2022-06 - 2025-12)
Plant approval: INVIMA (Colombia), EU, ANVISA (Brazil), Third Party Audit
- Handling of Change Controls and Deviations through the QMS software Master Control Software
- Review of risk/impact assessment & risk communication.
- Evaluation of Nitrosamine and Elemental impurities in Finished Formulation.
- Artwork Review
- To Check and perform Supply Chain Management (SCM) related Activities and Compliances. Perform investigation with the coordination with cross functional team for deviation.
- Handling of Market complaints.
- Lead and executed vendor qualification activities, conducting over 40 audits covering APIs, excipients, and primary packaging materials — including 7 on-site audits at domestic API manufacturers.
- Tracking of vendor's qualification, Handling of Material complaint (Supplier corrective action request), Vendor's site audit QMS activity related to vendor qualification
- Handling Quality Related activity of Third party and Loan licensing site.
QA Executive - IPCA Laboratories Ltd - Boisar, Palghar
(2021-11 - 2022-06)
Plant approval: WHO, Kenya, Uganda
- Routine Manufacturing compliances & in-process activities.
- Review and compliance of online e BMR and SOP's.
- Implementation of GMP, Quality Systems and procedures during the Manufacturing Process.
- Handling of Change Controls and Deviations through the QMS software Trackwise
- Review of risk/impact assessment & risk communication.
- Line Clearance of On-going Products for Dispensing, Manufacturing and Packing Operations.
- To Check and perform SCM related Activities and Compliances.
- Perform investigation with the coordination with cross functional team for deviation.
- Handling of Market complaints and to assist senior Site technical committee member in its related investigation.
- Annual Product Quality Review (APQR).
- On job training to IPQA and Production team on cGMP
QA Senior Officer - Intas Pharmaceuticals Ltd. - Matoda, Ahmedabad
(2017-04 - 2021-11)
Plant approval: USFDA, MHRA, TGA
- Routine Manufacturing compliances & in-process activities.
- Review and compliance of online e BMR and SOP's.
- Implementation of cGMP, Quality Systems and procedures during the Manufacturing Process.
- Handling of Change Controls and Deviations through the QMS software Q-edge.
- Review of risk/ impact assessment & risk communication.
- Line Clearance of On-going Products for Dispensing, Manufacturing and Packing Operations.
- To Check and perform SAP related Activities and Compliances.
- Perform investigation with the coordination with cross functional team for deviation.
- Handling of Market complaints and to assist senior of cross functional team (CFT) member in its related investigation.
QA Junior officer - Macleod Pharmaceutical Ltd - Sarigam - Vapi, Gujarat
(2016-04 - 2017-03)
Plant approval: USFDA, WHO
- Routine Manufacturing compliances & in-process activities.
- Communication to Superiors related to the Quality Assurance Activities on Daily basis.
- Review and compliance of online BMR and SOP's.
- Implementation of GMP, Quality Systems and procedures during the Manufacturing Process.
- Involved in QMS Activities like change control, deviation & CAPA.
- Involved in Process Validation Activities and Data Compilation.
- Annual Product Quality Review (APQR).
- Responsible for coordinating day to day activities of preparing, issuing, reviewing, maintaining, archiving and destruction of various Quality documents and maintaining the QA record room.
Quality Assurance Junior officer - Indoco Remedies Ltd - Waluj, Aurangabad
(2014-08 - 2016-03)
Plant approval: WHO, NDA Uganda, Kenya
- Routine Manufacturing compliances & in-process activities.
- Communication to Superiors related to the Quality Assurance Activities on Daily basis.
- Review and compliance of online BMR and SOP's.
- Implementation of GMP, Quality Systems and procedures during the Manufacturing Process.
- Involved in QMS Activities like change control, deviation & CAPA.
- Involved in Process Validation Activities and Data Compilation
Trainee - Sky Biotech Pharmaceutical Pvt. - Georai Tanda, Aurangabad
(2013-12 - 2014-07)
Plant approval: WHO
- Routine Manufacturing compliances, in-process control for solid dosage facility.
- Communication to Superiors related to the Manufacturing Assurance Activities on Daily basis.
- Review and compliance of online BPR's, Manufacturing Process and SOP's.
- Implementation of GMP, Quality Systems and procedures during the Manufacturing Process.
- Involve in Cleaning Validation like swab sampling and its Documentation.
- Line Clearance of On-going Products for Dispensing, Manufacturing and Packing Operations.
- Involve for Process Validation Activities and Data Compilation.
- Finished Product, Stability and Hold Time Study Sample Collection for Analysis.
