Job Description

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: Laboratory Operations and Quality Manager, Epidemiology Specialist, Plasma Quality Assurance, and Grifols Egypt for Plasma Derivatives plasma general management.

External: Third-party providers.

Key responsibility

To perform periodical review of Plasma Testing Laboratory records and ensure Good Documentation Practice (GDP) is followed.

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 reviewing 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.

Review Epidemiological data.

Ensures compliance with all regulatory agencies.

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, Pharmacist preferable.

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 in Pharmaceutical industry.

Computing Skills

Proficiency in Computers and Microsoft applications.

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.