Senior Quality Assurance Specialist

Job Description

● Presence at the contracted production companies and continuously monitor the relevant activities that are being carried out. ● Follow up on the quality activities of the production unit to ensure that the related processes are being implemented according to the standards. ● Prepare all documents related to production as well as technology transfer documents of foreign contracting companies. ● Prepare, develop, gather, and archive all quality assurance-related documents. ● Raise and investigate the production deviations and change controls. ● Cooperate in preparing the CTD dossier for the production unit. ● Prepare the relevant SOPs as well as process indicators in order to constantly improve the performance of production units according to the standards. ● Cooperate in the assessment of the candidate companies to work with Cobel Darou which may have an impact on the quality of the company's products. ● Cooperate in periodical inspections of the production contracting companies to ensure that the GXP activities are properly handled and prepare the relevant reports. ● Identify and design general and specific methods of work to improve the organization's processes for the effectiveness of activities. ● Analyze data to identify areas for improvement in the quality system and development.