KEY RESPONSIBILITIES :
- Development, review, revision and implementation of SOPs as required.
- Manage and evaluate (trending) complaints, deviations, Corrective Actions and Preventative Actions (CAPAs), and Change Control requested.
- Develop a system of control through main Quality KPIs.
- Assist Regulatory projects that involve QA oversight.
- Annual Quality reviews for compliance with Egyptian registration and licenses approved by Health Competent Authorities.
- Monitor QA aspects of Plasma Collection, warehousing, Testing and shipping practices for compliance with Egyptian Regulation and with Product licenses approved.
- Liaise with customers and regulatory authorities regarding quality matters, including hosting inspections and responding to observations
ACADEMIC EXPERIENCE REQUIRED :Bachelor s Degree in Health-related Sciences.Post-Graduate Certification in Quality Management.Knowledge of cGMP requirements preferredPROFESSIONL EXPERIENCE REQUIRED :Typically requires a minimum of 3 years of related experience. Blood banks or Pharma backgroundpreferred.