Saiful Alam Email & Phone Number

•About 20 years solid proven track record of success in Pharmaceutical industries, especially in Quality Assurance and Quality Control areas. This includes effective implementation of Quality Management System through effective change control, deviation & CAPA management, validation, complaint handling as well as qualification, operation, calibration & troubleshooting of equipment etc.•Experienced in managing, planning and supervising the Quality Control and Microbiology laboratories for Pharmaceuticals & Food Products.•Experienced in preparation of specification, test procedure, SOPs, Product Dossier, Validation Master Plan, & Site Master File etc.•Hands-on experience on Method, Process & Cleaning Validation•Practical experience on arrangement of new up-to-date sophisticated equipments for setting up a modern quality control laboratory (Generated list for required equipments, budget preparation & getting approval with proper justification,, preparation of URS, Technical evaluation & Communication)•Knowledge on establishing & implementing Key Performance Indicator (KPI) in meeting objectives for performance.•Capable of ensuring Laboratory compliance with GMP, GLP, ISO & National Regulatory Requirements•Experienced on preparing, performing, leading & managing QC audit.•Certified internal auditor for ISO 9001:2015;•Knowledge on internal and external auditing of quality systems and preparation of audit reports;•Visited International Pharma Expo (CPHI CHINA 2018 & CPHI INDA 2018) for gathering knowledge about new technology & many of the new things happening in the pharmaceutical industry.•Well versed in operating, troubleshooting and calibrating in all modern instrument such as HPLC, GC, AAS, UV-VIS Spectrophotometer, IR, Flame Photometer etc., as well as various other analytical techniques including Microbiology;•Knowledge on HVAC System, Water Purification System, and Effluent Treatment Plant (ETP)