Sr. Executive in Quality Assurance - Reliance Life Sciences - Rabale, Navi Mumbai
(2024-10-07)
- Prepare, review, issue, retrieve, and manage SOPs, Batch Records, Site Master Files (SMF), and quality documents through DMS.
- Review and release of in process and finished product batches in LIMS.
- Submission of Annual Notifications of all products to Regulatory Affairs.
- Review and closure of BMR's & BPR's in PAS-X.
- Preparation and review of Annual Product Quality Review (APQR).
- LIMS intimation of stability batches and approval of stability protocols.
- Co-ordination with production, QC, stores, engineering of facility to improve quality systems to ensure smooth manufacturing of products.
- Documentation and Data control.
- Providing training to team and cross functional group on SOP's and GMP topics.
Executive in Advance Characterization Laboratory - Encube Ethicals Private Ltd - Mumbai Andheri (Marol)
(2020-10-27 - 2024-09-27)
- Handled internal quality audit. Prepared and presented audit reports that reflect audits results and document process. (Compliance Reports)
- Prepared MDR, protocols and reports for Extractable and Leachables.
- Prepared URS, IQ/OQ and PQ documents.
- Handled tracking and closure of Change Control through trackwise software.
- Performed and tracked QMS activities (CAPA, Deviations).
- Reviewed and monitored Instruments/Equipment's calibration, Preventive Maintenance, Validation, periodic Audit Trial and periodic back up as per schedule.
- Handled GDP, GLP activities.
Research Associate in Corporate quality assurance department - Macleods Pharmaceuticals Ltd. - Andheri
(2018-02-05 - 2020-10-26)
- Prepared Specifications and Standard Test Procedures for APIs and Excipients covering US, EU, and Domestic markets.
- Supported Dermal, Hormonal, and Solid Dosage product portfolios.
- Coordinated with Analytical Development, Formulation Development, Regulatory Affairs, and Procurement departments.
- Managed Change Control activities through TrackWise software.
Research Associate in ADL department - Ajanta Pharma Limited - Kandivali
(2015-12 - 2017-03)
- Performed analysis of formulation development samples using HPLC, UV Spectrophotometer, and Dissolution Apparatus.
- Conducted calibration of HPLC, Dissolution Apparatus, UV Spectrophotometer, pH Meter, and Balances.
- Performed analytical and stability studies for DCGI products.
QC chemist - Milan Laboratory Pvt. Ltd. - Kalamboli (Panvel)
(2012-04 - 2014-12)
- Conducted stability testing of finished pharmaceutical products using HPLC, UV Spectrophotometer, and Dissolution Apparatus.
- Performed instrument calibration and maintenance.
- Managed documentation and record keeping.
