Center Quality Specalist - Banha

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 preferred

PROFESSIONL EXPERIENCE REQUIRED :

• Typically requires a minimum of 3 years of related experience. Blood banks or Pharma background
  preferred.