Laboratory Quality Assurance Specialist

Job Objective

• To assess performance of testing methods established in plasma testing laboratory making a
• follow up of Quality Control assessment of the results.
• To ensure that all methods are in correct validation status and participate in Proficiency testing
• studies.
• To review test results obtained in plasma Testing Laboratory.
  
  
  

Key responsibility

1- To perform periodical review of Plasma Testing Lab records.

2- To perform periodical equipment Quality Control review.

3- To perform periodical review of equipment incident logs.

4- Supervises operations, policies and procedures, workflow and activities of the laboratory.

5- Participate in generating and review of SOPs in Plasma Testing Laboratory.

6- Review Validation Testing methods in order to comply with cGMP requirements according to Egyptian regulation, as well as in accordance to FDA and European requirements.

7 Evaluate Quality Control programs established in Plasma Testing Laboratory.

8- Participate in Proficiency testing supporting Plasma Quality Control Manager, through Test results revision and evaluation.

9- Ensures compliance with all regulatory agencies.

10- Review and propose release of test results.

To support Plasma Quality

Academic Experience Required

• Bachelor s Degree in Health-related Sciences.
• Knowledge of Quality Control performance and Quality Assurance preferred.
• Knowledge of cGMP requirements preferred.
  
  
  

Professional Experience Required

Typically requires a minimum of 2 years of related experience in a similar position, in

environments of Good Manufacturing Practices GMP.

Personal Skills

• Organized and able to manage time effectively.
• Ability to work within a highly regulated, labor-intensive environment.
• Analytical and enquiring mind with the ability to interpret data and facts.
• Excellent oral and written communication skills to produce clear and concise factual findings and ability to present effectively to groups.
• Effective organizational and planning skills with ability to meeting deadlines required.
  
  
  

Languages

Written and spoken English and Arabic.