Job Objective :

To collect Epidemiological Data of GEPD Plasma Donors and report it to national authorities and

international bodies as PPTA and EMA. Using statistical methods for studying the distribution and

determinants affecting the occurrence of the disease.

Environment :

Internal: Center Quality Managers, Plasma QA Senior Manager, QC Plasma Sr Manager,

Regulatory Affairs Manager, QC and QA supervisors.

External: Health Authorities, Government Authorities and Auditors.

Key responsibility :

• Collect GEPD Plasma Donors Epidemiological data.
• Analyse the causes and locations of disease outbreaks.
• Prepare and arrange Data required by national amd international authorities according to

defined timelines.

• Compile and review all data related to plasma Quality control testing results.
• Propose and revise alert levels and Actions levels taking into consideration PPTA and EMA

(European Medicines Agency) framework.

• To open Deviation of those values outside the limits established.
• To perform a follow up after CAPA implementation.
• Knowledge of Epidemiological situation of the country in front of PPTA standards and European standards.
• Ensure adherence to regulatory requirements, international instructions and submission schedules.