Dr. Md. Zahurul Hossain

Current Roles:-

• 30 September 2021– till to date: General Manager, Quality Operations Division (Head of Quality Operations), The ACME Laboratories Ltd., Dhamrai, Dhaka, Bangladesh.
• Plan, organize and monitor overall activities of Quality Operations (i.e., Quality Assurance, Quality Control, Validation and Training & Development).
• Plan and implement the quality strategy in order to ensure seamless processes across the cGMP/Regulatory interfaces and maximize the quality and effectiveness and overall value of the quality operations.
• Approve/Authorize all the new and revised documents SOPs/specifications/ SMF/QM/VMP/BMR/BPR & method of analysis according to current compendia to ensure compliance with cGMP and ISO 9001:2015 standards.
• Ensure developing and maintaining GMP training plans, implement the training and monitored the training for effectiveness via the quality strategy group.
• Ensure to develop the overall quality audit plan (internal and external cGMP audit) in compliance investigations and timely follow up of all observations for a satisfactory conclusion.
• Ensure all types of the failure investigation i.e. OOS, OOT, Deviation, Customer Complaints etc. and act as a Product Recall process coordinator.
• Ensure and monitor all types of the Qualification, requalification, validation, Revalidation, PQR, Change Control, Risk Assessment, CAPA, & IPQA.
• Direct & take initiatives to achieve global regulatory certifications to enter global market and expand business globally.
• Ensure quality management review meeting as per SOP to discuss about outstanding and important issue and take necessary action for continual improvement of quality and organization.
• Assess the areas to determine the improvement with appropriate plan of action and carry out any other assignments given by the management to improve overall quality standard..

Education:-

• Doctor of Philosophy (Ph.D.) in Biochemistry (Enzymology), 1996, Kagoshima University. Japan.
• Master of Science (Thesis Group) in Biochemistry, 1985 Secured First position in the First Class, Dhaka University.
• Bachelor of Science with Honours in Biochemistry 1984 First Class, Dhaka University.