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 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.
Grifols Egypt for plasma derivatives is a joint-venture (JV) company between the Egyptian Government, through the National Service Projects Organization (NSPO) and Grifols, the global leader in plasma medicines with more than 110 years of contribution to improving the health and well-being of people.
This joint venture is the first of its kind in the plasma industry and the first-ever Egyptian source member of the Plasma Protein Therapeutics Association (PPTA). GEPD is a groundbreaking global public-private alliance that will benefit the entire region.
GEPD is committed to developing the plasma medicines market and achieving self-sufficiency in these critical therapies, which is crucial for the Egyptian healthcare system.
We are combining the expertise of both shareholders to build and operate 20 plasma donation centers throughout Egypt, along with manufacturing facilities including fractionation, purification, and fill-and-finish plants with a processing capacity of up to 1 million liters of plasma annually that can double in the future.
The new manufacturing facility will include a plasma warehouse and a testing laboratory. It will occupy 105,000 square meters strategically located in the administrative capital’s medical city, adjoining various healthcare institutions.
