Md Saiful Islam Phd Email & Phone Number

United States

Long Island, Ny, United State

Shafipur, Gazipur

To plan, organize, co-ordinate, control and monitor personnel, equipment and materialsMonitoring and ensure overall Operational Activities of QC department in accordance with GLP, WHO-cGMP, ICH, MHRA, PIC/S & TGA guidelineManage laboratory operation of various pharmaceutical dosage form (Tablet/Capsule/Dry Syrup/Liquid/Cream, Ointment/Eye Drops/Injectables etc)Approval or rejection of starting materials, packaging materials, intermediate, bulk and finished productsEvaluation of batch recordsTo ensure that all necessary testing are carried outTo approve sampling instructions, specifications, test methods and other quality control proceduresOperation and calibration of all QC instrument i.,e. UV-VIS Spectrophotometer, HPLC, FTIR, AAS, GC, ICP-OES, Dissolution Tester etc.Development and Validation of Analytical Method as per international guidelinePerform Export Documents for registration of products for Philippines, Kenya, Bhutan, Myanmar, Afghanistan, Uzbekistan, Sri Lanka, Yemen, Vietnam, Cambodia etc.Ensure the Vendor approval of incoming & existing RM & PM samples with proper documentationsMonitoring Stability Testing of all new and existing products to assure the safety, efficacy and quality of products per regulatory guidelinesPerform Deviations Control, Out of Specification Results (OOS) and Change Control with proper investigations & documentationsEnsure personal hygiene, sanitation and microbial tests of RM & finished productsPerform and monitoring all necessary tests for newly launched products, Raw & Packing materials, and finished productsDevelop the methods of dissolution and impurities for incoming materials & finished products and carry out multipoint dissolution profiles for comparisonTo check the maintenance of department, premises and equipmentTo ensure that the appropriate Validation including those of analytical procedures, manufacturing procedures and calibration of Quality Control equipment are done

Savar, Dhaka, Bangladesh

Monitoring and ensure overall Operational Activities of QA/QCPrepare, review and approve of all types of documents (new and revised) like SOPs/Quality Manual/DMF/ SMF/VMP/ Specifications/BMR & BPR etc.Ensure the Compliance of documentation with cGMP, & ISO 9001-2008 standardsEnsure finished products are correctly processed with appropriate approval of BMR/BPR and all necessary tests are carried out before release for saleEnsure Internal Audits (e.g. self-inspection/GMP audit, Vendor audit etc.) and conduct GMP & on job training for the employeesEnsure Cleaning Validation of Processes and Equipments as per approved ProtocolPerform Corrective and Preventive actions (CAPA) are taken for all observations recorded during External and Internal auditsHandling the Product Complaints effectively with proper investigations and prepare yearly departmental objectives, achievement and budget with follow-up for their implementation.

Tejgaon, Dhaka

Worked as head of QC and ensure overall Operational Activities of QC department in accordance with GLP, WHO-GMP, ICH guidelinesDevelopment and validation of analytical methods as per international guidelinesPerform calibration of measuring equipments and Validation & Qualification of machineriesPrepare and updates all necessary GMP documents (e.g. SOPs, specifications of RM, PM & finished products etc.)Perform and organize the ongoing stability studies activities for existing productsMonitoring In-Process Control activities for all bulk, intermediate & finished products

Tongi, Gazipur, Bangladesh

Monitoring and ensure overall Operational Activities of QC department in accordance with GLP, WHO-GMP, ICH guidelinesPerform Export Documents for registration of products for Philippines, Kenya, Bhutan, Myanmar, Afghanistan, Uzbekistan, Sri Lanka, Gambia, Yemen, Vietnam etc. Development of analytical methods with appropriate Validation as per international guidelinesPerform calibration of measuring equipments and Validation & Qualification of machineriesPrepare and updates of all necessary GMP documents (e.g. SOPs, specifications of RM, PM & finished products etc.)Perform and organize the stability studies activities of both accelerated & long term (Real- time) for all newly launched & existing products respectivelyPerform to meet all statutory and regulatory requirementsMonitoring In-Process Control activities for all bulk, intermediate & finished products

Bogura, Bangladesh

Confirm the test and analysis of intermediate, bulk and finished products as per GLP, WHO-GMP, ICH guidelinesDevelopment and validation of analytical methods as per international guidelinesPerform calibration of measuring equipments of QC DepartmentPrepare and updates all necessary GMP documents (e.g. SOPs, specifications of RM, PM & finished products etc.)Perform and organize the ongoing stability studies activities for existing productsPerform the preparation of Working Standard & Standardization of regents with maintaining proper recordsPreparation of Recipe, Annexure and packing specifications of New ProductsCost effective formulation of new and existing products

Shafipur, Kaliakoir, Gazipur, Bangladesh

Perform the preparation of Working Standard & Standardization of regents with maintaining proper recordsPreparation of Recipe, Annexure and packing specifications of New ProductsDevelopment of Manufacturing Formula of new productsCost effective formulation of new and existing productsPreparation of SOP and product batch record as per recommendation of ISO 9001:2000

M.Sc., Organic Chemistry, Higher Second Class

Doctor Of Philosophy - Phd, Analytical Method Development And Validation (Pharmacy), Passed

Master Of Business Administration (Mba), Management, 3.5 Out Of 4.0

Bachelor Of Science (Bsc), Chemistry, Upper Second Class

Hsc, Science, First Div

Ssc, Science

Doctor Of Pharmacy - Pharmd, Pharmacy, Passed

Activities and Societies: Life member of Bangladesh Society for Pharmaceutical Professionals (BSPP)Analytical Method Development.