Rashedul Islam Email & Phone Number

Tianjin, China

Chongqing, China

Analytical leadership role reporting to Director, QC. Serving as a team leader of QC project teams which is mainly responsible for the project from US and EU companies such as Johnson and Johnson, Merck, Roche, Pfizer, Sumitomo Pharma Japan-USA, etc.As a project leader of QC in a CRO-CDMO-based pharma company, I am mainly responsible for preparing, reviewing, and implementing different kinds of quality documents such as SOPs and Specifications for every stage API and Intermediate… Show more Analytical leadership role reporting to Director, QC. Serving as a team leader of QC project teams which is mainly responsible for the project from US and EU companies such as Johnson and Johnson, Merck, Roche, Pfizer, Sumitomo Pharma Japan-USA, etc.As a project leader of QC in a CRO-CDMO-based pharma company, I am mainly responsible for preparing, reviewing, and implementing different kinds of quality documents such as SOPs and Specifications for every stage API and Intermediate product. In addition, to make plans and prepare protocols for stability samples of different projects.As a project leader, I have been maintaining deep communication with client's through verbal and email from US and EU and doing collaboration work along with fulfilling client's all QC-related requirements and feedback.I participate in strategic planning, portfolio analysis, budget and resource allocation, and assessment for the quality operations department.As project manager of QC, I have been preparing and reviewing Analytical method validation, verification and transfer protocol, report and related documents. Moreover implement the change control and action plan for changes.I implement and follow up the investigation process for Deviation and OOS along the same line use GMP TrackWise system for OOS handling.I have been implementing and performing the GMP operation procedure by LIMS system for corresponding quality management.I train the analytical scientist in different kinds of analytical procedures and instruments to strengthen analytical knowledge and troubleshooting. Show less

Zhangjiakou, Hebei, China

* Performing project management along with method development, method validation, and method transfer of new analytical method of Starting material, API, and Finished product. (Assay, Dissolution, and Related substance).* Preparing and reviewing validation protocols/reports and analytical reports including data.* Overseeing analysis team for analysis of Finished product, raw materials, bulk sample analysis, and hold time study.* Preparation and updating of Specification, analytical… Show more * Performing project management along with method development, method validation, and method transfer of new analytical method of Starting material, API, and Finished product. (Assay, Dissolution, and Related substance).* Preparing and reviewing validation protocols/reports and analytical reports including data.* Overseeing analysis team for analysis of Finished product, raw materials, bulk sample analysis, and hold time study.* Preparation and updating of Specification, analytical report, and Standard Test Procedure for Raw Material, Packaging Material, and Finished Product as per Pharmacopeia/ Manufacturer’s guideline/ Validation report.* Participating in the lab investigation and deviation investigation, ensuring the OOS/OOT and deviation investigation report scientifically, logically, and reasonably. * Performing hypothesis analysis for out-of-specification (OOS) results.* Executing and analysis planning of comparative dissolution study and force degradation study in ARD Laboratory.* Preparing FDA audit documents and preparing all facilities as per FDA instructions. Show less

* Performing analysis of method development, method validation, and method transfer of new analytical method (Assay, Dissolution, and Related substance).* Preparing and reviewing validation protocols/reports and analytical reports including data.* Maintenance and operating of analytical instruments which include HPLC, UV FT-IR Dissolution apparatus, weighing balances, pH meter, conductivity meter, etc.* Online documentation of all validation results in compliance with Good… Show more * Performing analysis of method development, method validation, and method transfer of new analytical method (Assay, Dissolution, and Related substance).* Preparing and reviewing validation protocols/reports and analytical reports including data.* Maintenance and operating of analytical instruments which include HPLC, UV FT-IR Dissolution apparatus, weighing balances, pH meter, conductivity meter, etc.* Online documentation of all validation results in compliance with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).* Conducting Laboratory Incident Report (LIR) for any kind of occurrence during analysis time.* Maintaining the chemical laboratory facilities, instrumentation, and chemicals inventory for the proper functioning of the laboratory, while maintaining quality and safety precautions.* Ensure Good Laboratory Practice at the laboratory.* Preparing dossier of different products for export purposes.* Preparing and executing laboratory sops and EOPs. Show less

Gazipur, Dhaka

 Performing analysis of Finished product raw materials, bulk sample analysis, and hold time study. Performing assay and related substance testing, Content Uniformity, Dissolution, and Blend Uniformity as per in-house, USP, or BP monograph. Participate in the lab investigation and deviation investigation, ensuring the OOS/OOT and deviation investigation report is scientifically, logically, and reasonable. Confirm all tests as per Standard Testing Procedure and report… Show more  Performing analysis of Finished product raw materials, bulk sample analysis, and hold time study. Performing assay and related substance testing, Content Uniformity, Dissolution, and Blend Uniformity as per in-house, USP, or BP monograph. Participate in the lab investigation and deviation investigation, ensuring the OOS/OOT and deviation investigation report is scientifically, logically, and reasonable. Confirm all tests as per Standard Testing Procedure and report details. Handling of all sophisticated QC instruments like HPLC (Waters, Dionex, Shimadzu, and Agilent), UV-Vis Spectrophotometer, FTIR, AAS, TLC, TOC, Potentiometer, Conductivity Meter, pH Meter & Dissolution Tester, etc. Online documentation of all test results, records, and reports test data correctly, completely, and accurately within the company and departmental policies and guidelines. Preparation of volumetric solution (VS), test solution (TS), reagent solution, CCR & Export documents. Some special work during audit like FDA, TGA, MCC, MHRA Show less

Master’S Degree, Chemistry, 1St Class

Result: 1st class (with 60% marks)

Bachelor’S Degree, Chemistry, 1St Class

Activities and Societies: Result: 1st class (with 62% marks)