Quality assurance document for pharmaceutical based on WHO-GMP guidelines
I am working as Quality Assurance Manager at Sharif Pharmaceuticals Ltd., Bangladesh since 2016 and my task covers to Face audit to local drug regulatory inspector, to prepare & update SOP, site master file, quality manual ISO 9001:2015, Validation Master Plan (VMP), GMP manual, root cause analysis, CAPA, training, risk analysis using FMEA, checking lay-out of pharmaceuticals, process validation, equipment qualification, cleaning validation, HVAC , calibration, the test method of QC including microbiology, preventive maintenance of equipment, Formulation & stability study of medicine, customer complaint handling, annual product quality review, Water treatment plant , Effluent treatment plant, housekeeping, In-process control, Incinerator, vendor qualification, motivation to establish QA system on production, warehouse, quality control, distribution, and maintenance department. Formerly I worked as R & D manager in Jayson Pharmaceuticals for 2 years and also worked as production Manager-vet in Acme Laboratories for 3.5 years.