- LocationEgypt
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IndustryMedical
Responsibilities & Duties:
● Responsible of ensuring that Quality System in place is in compliance with Egyptian Regulation and in accordance to FDA and EMA Regulation, staying abreast of current and new regulations in order to analyze their impact on Quality system established It is responsible of performing a periodical assessment of Quality system through different KPI’s established
● Prepare all the documentation related to Technical Information referred to Blood Establishments (Plasma Centers, Plasma Logistic Centers (PLC) and Plasma testing laboratory).
● Prepare Site Master file of all Blood establishments
● Submission of all documentation related to the Application of Blood establishments involved along plasma supply chain, to Health Authorities
Requirements:
● Bachelor ‘s Degree in Health-related Sciences
● Knowledge of Quality Management.
● Knowledge of cGMP requirements preferred
● Typically requires a minimum of 2 years of related experience in a similar position, preferably in a pharmaceutical and multinational context, in environments of Good Manufacturing Practices GMP
● Proficiency with computers
● Written and spoken English and Arabic
