
Pranab Kumar
Analytical Research and Development / Quality Control
男36 岁医药研发/药品生产住在 孟加拉国国籍 孟加拉国
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简介
Accomplished Pharmaceutical Analytical Professional with 10 years of experience in R&D Analytical and Quality Control Departments. Possesses strong expertise in the analysis of pharmaceutical raw materials, finished products, and stability samples, with proven problem-solving skills and the ability to work collaboratively in cross-functional teams.
Highly experienced in analytical method validation using a wide range of laboratory instruments, including HPLC, GC, ICP-OES, Potentiometer, Particle Size Analyzer, and Dissolution Tester. Demonstrated success in leading high-stringency regulatory projects such as Azithromycin Tablets, Pregabalin Capsules, Atorvastatin Tablets, Montelukast Tablets, Lansoprazole Capsules, and 4-FDC Tablets, securing approvals from USFDA, EU GMP, and WHO.
Recipient of the “Top Performance Award” at General Pharmaceuticals Ltd. for outstanding contributions during the EU GMP audit and for developing and implementing an in-house analytical equipment calibration procedure, achieving significant cost savings for the R&D Analytical Laboratory. Experienced in successfully handling global regulatory audits (USFDA, EU GMP, WHO, and others) while ensuring full compliance and driving continuous process improvement.
工作经历
Senior Executive R&D Analytical
General Pharmaceutical Limited, Bangladesh2022.12-至今(3 年)1. Supervised the team for stability studies and raw materials source approval, allocated work to team members, and mentored them in troubleshooting analytical techniques. 2. Led the project and execute analytical method validation for various highly regulatory markets, including USFDA, UKMHRA, and EU GMP. 3. Perform validation of Analytical method using HPLC, GC, ICP-OES, Potentiometer and Particle Size Analyzer etc. 4. Responsible for RLD Characterization, dissolution profiling and feasibility study for USFDA and EU and WHO project. 5. Investigation of Lab deviations, OOS and OOT’S through quality management system. 6. Performed cleaning method validation 7. Prepare and review of method validation protocols, reports, method transfer protocol. 8. Calibration and maintenance of laboratory equipment 9. Preparation of SOP, STP, Specification and Analytical Data Sheet (ADS) 10. Monitoring and completion of different projects within stipulated time lines.
语言
英语
精通
证书
技能
Analytical method development and validation, Analysis, Calibration, Documentation, Leadership
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