Job Objective :
To review and assess all procedures, testing methods and reports established in Plasma
Testing Laboratory are in compliance to Egyptian regulations, and in accordance to cGMP,
following Plasma Testing Specifications established and European Regulation.
Environment :
Internal: Laboratory Operations Manager, CQMs, Epidemiology Manager, Plasma QA
Senior Manager, QC Plasma Sr Manager, QC testing Specialist and QA Specialist.
External: Health Authorities, Government authorities and auditors.
Key responsibility :
- To ensure periodical review of Plasma Testing Laboratory records and logs.
- To initiate investigation for incidents and perform root cause analysis.
- To supervise routine plasma screening tests results.
- To review operations, policies procedures and workflows of the Laboratory.
- To review analytical methods validation protocols and reports.
- To review laboratory procedures and reports.
- To ensure the calibration and maintenance program for the Laboratory equipment is performed as planned.
- To train, supervise and support Quality Assurance specialists to ensure tasks are
performed correctly.
- To perform Quality Risk assessment studies and create reports.
- To support data retrieval and Epidemiology reports review generated at Plasma Testing
Laboratory.
- To participate and support internal and external regulatory inspections and audits
performed in the Laboratory.
- To ensure compliance with regulatory authorities.
Academic experience required :
- Bachelor's degree in health-related sciences.
- Preferably master's degree or Diploma in Quality assurance.
Professional Experience Required :
- Minimum 5 years of experience in certified laboratories.
- Knowledge in Good Laboratory Practices (GLP's).
- Minimum 5 years of experience in a similar position, in environments of Good
Manufacturing Practices GMP.
Computing Skills :
Proficiency in Computers especially Xcel.
Languages :
Fluent English and Arabic language.
