$ Working as an SME (Subject Matter Expert) for local and international regulatory audits.$ Managing quality tools such as QRM, OOS, OOT, Deviation, Change Control, QIR, and CAPA for ANDA projects and other regulatory products.$ Leading the QC laboratory team in analyzing Finished products, Raw materials, Packaging materials, Water samples, Validation batches, and Method transfers for local and ANDA markets.$ Managing the release of Finished products, Packaging materials and Raw materials in the SAP system including creating specifications, data input, usage decision and COA preparation.$ Managing ANDA project activities, including communication with Contract Givers, specification setting, method transfers, and stability studies.$ Ensuring adherence to cGLP, GCP, data integrity, and laboratory safety while leading the revision of SOPs, EOPs, and ECPs as per current pharmaceutical guidelines.$ Leading teams for Blend Uniformity Testing, Split Tablet Studies, Cleaning Validation, Hold time studies and Stability-indicating method development & validation in compliance with regulatory guidelines.$ Handling instrument calibration, OOC (Out of calibration), and troubleshooting for HPLC, UV, AAS, GC, and other sophisticated instruments.$ Coordinating outsourcing of laboratory testing for raw materials and products related to regulatory requirements.$ Facilitating cross-department communication with QA, RA, ARD, and others to ensure smooth QC operations.

$ Supervise and monitor work distribution, analysis organization, and quality control for Bulk products, Raw materials, and Packaging materials.$ Review and verify documents, including analytical methods, calibration logs, validation records, and water quality reports.$ Release Bulk products, Raw materials, and Packaging materials through SAP as required for production or QA.$ Develop and review instrument methods/projects (HPLC, GC, UV, Potentiometer, AAS) and manage chromatographic system sequences.$ Prepare and update Methods, Specifications, SOPs, EOPs, and ECPs related to Bulk products, Raw materials, and laboratory activities.$ Monitor and troubleshoot analytical activities, including OOS, OOT, LIR, QIR, deviations, and related QMS investigations.$ Organize sampling, analysis, retention, and disposal of laboratory and production samples.$ Train junior colleagues on instruments, reagent handling, glassware usage, and laboratory practices.$ Ensure data integrity, perform Level 1 self-inspections, and raise CCR, CDR, OOS, and risk assessments via EQMS.$ Monitor laboratory conditions (temperature and humidity) and conduct analyst validation programs.

$ Conduct analysis of active ingredients and excipients in raw materials for both ANDA projects and the local market.$ Organize sampling as per the sampling plan and ensure proper preservation of retention samples.$ Prepare and standardize volumetric solutions and test solutions to facilitate smooth analysis.$ Maintain accurate documentation and logbooks throughout all stages of analysis.$ Prepare and manage the sample quantity list for raw materials.$ Preparing, updating, and providing training on SOPs, EOPs, ECPs, and protocols related to quality control.$ Updating methods and specifications of raw materials to align with current compendia requirements and addressing CCR, CDR, and risk assessments related to methods, specifications, or CAPA.

$ Conduct analysis of biotech products such as Filgrastim, Peg-Interferon, and Erythropoietin, along with raw materials and finished products.$ Perform sampling of water, APIs, and auxiliary materials while ensuring proper retention sample storage.$ Prepare and standardize volumetric solutions for analytical processes.$ Develop and update methods of analysis and specifications for raw materials.$ Maintain compliance with cGMP, GLP, and good housekeeping practices in all laboratory activities.