Worked as part of Corporate QA department, Aurobindo Pharma. Major work responsibilities are based on Quality Assurance process implementation across 6 production units. Worked on Quality Management System(QMS) and Laboratory Information Management System(LIMS) to meet quality compliance in Drug manufacturing.• Review batch manufacturing and analytical test results to determine if product/material process and specifications have been met.• Involved in the end to end process of Incident logging, managed approval chain and resolution which includes corrective and preventive actions as an initiative of CAPA Management.• Report deviation in the manufacturing process which are not in line with established standards.• Coordinate preparation, review and issue of Standard Operating Procedures (SOPs), GTPs, STPs including support and maintenance.• Implemented Change Control process for all new concluded changes in the QA process and approved in the documentation.• Taken responsibility to incorporate the changes in the documents approved by the QA Manager, the changes are permanently made and followed until another change request is generated.• Followed Good Manufacturing Practice (GMP) guidelines.

• Responsible for Preparation of Master documents in LIMS (Ex. Product/Material, Specification ID, Test & Worksheets).• Worked on LIMS modules like sample manager, system manager and resource manager.• Had involved in creating master profile for various products(pharmaceutical) using sample manager• Using system manager taken part in LIMS application administrative activities.• Registration of SAP, ERP code on LIMS application for raw material, finished and packaging materials. Ensured SAP records are appropriate for various ERP codes and specifications.• Followed Good Manufacturing practices (GMP) in QA role activities and evaluating the QC test reports which are subjected to Good Laboratory practices (GLP).• Uploaded/updated reference documents into LDMS (Lab documents management system) which is part of resource manager.• Involved in Documentation work as part of QA activities which includes report generation

Joined as a graduate trainee in QA entry level position. I have undergone on job training on Pharmaceutical QA methods and processes. Trained on LIMS application to implement QC process. As a beginner to LIMS, worked on migrating the existing manual work procedures to automated Quality Control process. • Have done Documentation work like Issuance and Control of Batch Manufacturing Records(BMR), Batch Packing Records(BPR), QC Analytical worksheets and formats.• Responsible for Preparation of Master documents in LIMS (Ex. Product/Material, Specification ID, Test & Worksheets).• Worked on LIMS modules like sample manager, system manager and resource manager.• Had involved in creating master profile for various products(pharmaceutical) using sample manager• Develop and complete Product Quality Review reports as per the PQR schedule