1. Execute Analytical method Development activities of drug products based on QbD principles andregulatory requirements.2. Execution of Analytical Method validation activities for drug products as per the regulatory requirements.3. Execute routine Analytical Research activities of drug products.4. Establishing In-house systems and procedures to ensure cGLP practices & regulatory requirements foranalytical activities at In-house R&D facility.5. Trouble shooting related to Testing methods, Stability studies, test results and designing of additionalexperimentations as necessary6. Execution & coordination for Analytical method transfer activities of drug products.7. Technical assessment & Analysis of drug substances (API) for projects execution.

Supervise routine activities of QC for testing and release of Raw materials, Finished Product, Packaging materials and Stability Study of samples.▪ Review of Analytical Documents, supervise testing of routine samples and troubleshoots equipment.▪ Prepare SOP, Protocols, Method and Specifications and arrange training to proper implementation.▪ Raise, handle and summarize report of investigation of Out of Specification, Out of Trend, Laboratory Investigation report, Deviation, CAPA etc▪ Ensure GLP by monitoring the management of reagent/CRS/WS/Column(HPLC/GC)/Volumetric Solution/Sample disposal/ Calibration Schedule etc.▪ Perform URS preparation of Instruments and also perform IQ, OQ, PQ and Calibration record of Laboratory instrument.▪ Perform Analyst Qualification Activities and provide training to the fresh analyst to develop manpower.

Supervise routine activities of QC activities for testing and release of Raw materials, Finished Product, and Stability Study.▪ Review of Analytical Documents, supervise testing of routine samples and troubleshoots equipment.▪ Prepare SOP, Protocols, Method and Specifications and arrange training to proper implementation.▪ Raise, handle and summarize report of investigation of Out of Specification, Out of Trend, Laboratory etc.▪ Ensure GLP by monitoring the management of reagent/CRS/WS/Column(HPLC/GC)/Volumetric Solution/Sample disposal/ Calibration Schedule etc.▪ Perform URS preparation of Instruments and also perform IQ, OQ, PQ and Calibration record of Laboratory instrument.▪ Perform Analyst Qualification Activities and provide training to the fresh analyst to develop manpower.• Have good skill of handling CAPA, CCR, Risk analysis and Other QMS tools of quality assurance.• Dealt with regulatory audits and completed US-FDA, UK-MHRA, TGA-Australia, WHO audits successfully.

▪ Involve testing of Insulin drug products under contract manufacturing project by Novo Nordisk, Denmark with Eskayef Bangladesh Ltd. Involved with following activities▪ Perform testing of Finished Product (Tablet, Capsule, Powder for Suspension, Sterile products, Large volume parenteral products etc)▪ Perform Calibration of the QC equipment (HPLC (Empower, LabSolution and Chromeleon software) GC, pH, UV-Vis spectrophotometer, Dissolution tester, Liquid Particle counter)