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.

Environment :

Internal: Plasma Testing Manager, Epidemiology Manager, Plasma Quality Control Manager, Plasma Quality Assurance, Quality Senior Director, Administration & Services divisions, and Grifols Egypt for Plasma Derivatives plasma general management.
External: In absence of Laboratory Quality Assurance Manager, Health Authorities, Government authorities and auditors.

Key Responsibilities  :

To perform periodical review of Plasma Testing Lab records.
To perform periodical equipment Quality Control review.
To perform periodical review of equipment incident logs.
Supervises operations, policies and procedures, workflow and activities of the laboratory.
Participate in generating and review of SOPs in Plasma Testing Laboratory.
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.
Evaluate Quality Control programs established in Plasma Testing Laboratory.
Participate in Proficiency testing supporting Plasma Quality Control Manager, through Test results revision and evaluation.
Ensures compliance with all regulatory agencies.
Review and propose release of test results.
To support Plasma Quality Control Testing Laboratory Manager of data retrieving process related to testing laboratory.

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.

Language :

Written and spoken English and Arabic.