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.
