Operation of the quality management system in accordance with GMP , ICH Q7A , Divisional policies , and company SOPs regulations. Tracking and implementing global corporate strategies. Ensure and continuous improvement the product quality. Preparing statistical reports for management within the framework of the monthly quality council. Making quality risk analysis. Coordination of laboratory and manufacturing deviation investigations. Control the issuing and change of the master batch records. Review and release of batch records . Validations (cleaning, process, RO water system , temperature, process control and data acquisition computer system) management . Preparation of annual product reviews. Preparation of annual maintenance review. Performing internal audits in the laboratory, factory, warehouse. Leading of customer audits. IQ, OQ supervision. Environmental Monitor sampling points and requirements setting, performing sampling. Writing, and coordinate the implementation of the issuance SOPs, work instructions, and specifications.Controlling the maintenance activity in quality point of view. New employee trainings, annual refresher trainings, carry out and coordination of trainings of the relevant SOPs. Maintaining the change control system. Investigation of customer complaints.