*Compilation of high-quality Annual Reports for submission to USFDA as part of Pfizer's Hospital Business Unit (Sterile Injectables) *Peer review of Annual Reports to ensure high-quality CMC submissions to USFDA*Received appreciation from global peers for identification of critical CMC errors and for compilation of high-quality submissions.

*Preparation of Technical documents related to Intervention trending for Aseptic Process Simulation on Liquid vial, Lyo vial, Cartridge and PFS lines. Introduced major changes bringing structure and procedural clarity to the document.* Initiation and implementation of CAPA related to process improvement leading to reduction in frequency and duration of interventions during aseptic batch filling operations. * Preparation of Protocol for operator qualification for physical inspection of filled Vials & Cartridges. * Checking CAPA effectiveness in the manufacturing facility.* Initiation of Deviations, Change Controls using TrackWise software as part of Quality Management System.* Trained and qualified in visual inspection of media filled units as part of Aseptic Process Simulation (Vials, Cartridges, Pre-Filled Syringes).* Revision of SOP's related to the manufacturing facility.* Prepared SLIA for peristaltic pumps.* Handling of Building Management System (BMS) using Niagara software and Particle Measuring System (PMS) using FacilityPro software; generated BMS and PMS reports on time and involved in preparation of BMS and NVPC monthly and yearly trend documents. Responsible for initiating breakdown notifications in SAP.* Handling and archival of documents and logbooks pertaining to manufacturing area in an efficient manner. Prepared tracker using Microsoft Excel for issuance, archival and vendor management of logbooks.* Involved in material management of the manufacturing area.*Escorted visitors to the DP manufacturing area during facility visit and briefing them regarding the overall manufacturing process.* Followed cGMP practices and online documentation.