Develop, implement, and maintain quality management systems and compliance policies
Handle the change control to manage all changes that can impact product SISPQ
Handle the Deviation management system and perform the deviation documentation, investigation, assessment, tracking, archiving and ensure that the appropriate corrective and preventive actions are set.
Handle the General CAPA System raised from All Quality Related Systems (Internal Audits, External Audits, Deviations, Events, Customer Complaints, Risk Assessment or Recalls) and its follow up to ensure the effective implementation of the actions all over the site
Handle the Customer Complaint Management System and perform its investigation, root cause identification and ensure that the appropriate corrective and preventive actions to prevent its recurrence are set if needed.
Analyze the risks to find out the amount & weight of the risk , as well as the frequency of its recurrence and the consequences of its occurrence
Assist in the preliminary analyses necessary for the preparation of monthly risk management reports.
Following up the mitigation actions plan & implementation
Investigate the issues related to the assessment
Perform training for staff on GXP & Data integrity
