Suhinatul Shrabani

Experience

• 

  Beximco Pharmaceuticals Ltd.

  Aug 2014 - now

  -Performing analytical method development (specially for Related Substances) for Oral Solid Dosages products, Respiratory & Sterile products of US-FDA project, TGAand other Regulatory market. -Performing, planning and reviewing analytical method validation, analytical method transfers and cleaning validation for Oral Solid Dosages products, Respiratory &Sterile products of US-FDA project, TGA and other Regulatory market.-Responding queries (Analytical Part) generated by US FDA, TGA and any other regulatory agencies against dossier or application. -Preparation and implementation of SOPs, Guideline and GMP, GCP/GLP compliance document associated with US-FDA, TGA, ANVISA, WHO and Heath Canada approvals. -Trend investigations, Risk assessment, Audit responses and assisting ANDA submission.-Troubleshooting, Preventive maintenance and Calibration of HPLC, Dissolution Tester and Analytical Weighing Balance. - Preparing Excel Spreadsheet and Performing Excel Spreadsheet validation.- Product Characterization and Carryout Formulation development, Packaging Development of sterile, Solid, liquid and other dosage form for domestic and regulated market. - Preparation of Protocol and report for Pharmacokinetics and Drug Disposition studies, Stability Studies, Bioanalytical Testing, Clinical Trials Show less -Performing analytical method development (specially for Related Substances) for Oral Solid Dosages products, Respiratory & Sterile products of US-FDA project, TGA and other Regulatory market.-Performing, planning and reviewing analytical method validation, analytical method transfers and cleaning validation for Oral Solid Dosages products, Respiratory & Sterile products of US-FDA project, TGA and other Regulatory market.-Responding queries (Analytical Part) generated by US FDA, TGA and any other regulatory agencies against dossier or application.-Preparation and implementation of SOPs, Guideline and GMP, GCP/GLP compliance document associated with US-FDA, TGA, ANVISA, WHO and Heath Canada approvals.-Trend investigations, Risk assessment, Audit responses and assisting ANDA submission.-Troubleshooting, Preventive maintenance and Calibration of HPLC, Dissolution Tester and Analytical Weighing Balance.-Preparing Excel Spreadsheet and Performing Excel Spreadsheet validation.-Product Characterization and Carryout Formulation development, Packaging Development of sterile, Solid, liquid and other dosage form for domestic and regulated market.-Preparation of Protocol and report for Pharmacokinetics and Drug Disposition studies, Stability Studies, Bioanalytical Testing, Clinical Trials. Show less 1. Analytical Method Development and Preparation of Standard Testing Procedure.2. Preparation of Product Dossier and other Regulatory Documents and Export Documentation Work.3. Analysis of Trial Batch and Scale up Batch for New Product.4. Calibration of Laboratory Apparatus and Ensure GLP Practice and Communication with Warehouse, Engineering, Quality Control, Quality Assurance and others. 5. Set up of Specification and Source Approval for Finished Product, Newly Formulation, Raw Materials and Packaging Materials.6. Stability Study and Preparation of Stability Study Report.7. To perform calibration of lab equipment and their proper recording. Show less

  • Assistant Manager

    Jul 2023 - now

  • Senior Officer, Research and Development

    Jul 2018 - now

  • Officer, Research and Development

    Aug 2014 - Jul 2018