JOB OBJECTIVE
- To execute the validation plan established.
- To perform testing following established procedures.
- To support Plasma Quality control Manager in the edition of SOP and documentation of support.
KEY RESPONSIBILITIES
- To execute all the protocols related to the different tests in order to have all testing methods in use in a correct status of validation following the guidelines established by Plasma Quality Testing Laboratory Manager.
- To elaborate initial validation protocols and initial validation reports for being further reviewed by Plasma Quality Testing Laboratory Manager.
- To perform tests following established procedures.
- To register and inform of possible deviations occurred during testing and propose measures for improving in the routine analysis.
- To perform routine maintenance of equipment involved in sample preparation and testing as well as the necessary verification for the correct care of the equipment.
- Preparation of all the material involved in testing performance and the preparation of the sample.
- To receive and prepare plasma samples for further testing.
- To introduce data results related to validation, test performance or deviations into the established systems for it.
- To perform verification and calibration assay using International standards.
- To support Plasma Quality Control Testing Laboratory Manager of data retrieving process related to testing laboratory.
ACADEMIC EXPERIENCE REQUIRED
Bachelors degree in Health-related Sciences.
PROFESSIONAL EXPERIENCE REQUIRED
Preferably At least 2 years of experience in a similar position, in environments of Good Manufacturing Practices GMP.
COMPUTING SKILLS
Proficiency in Computers.
PERSONAL SKILLS
- Ability and willingness to study specific activities, in a short time.
- Accuracy and reliability.
- Excellent management of priorities.
- Ability to work in groups and with other departments.
- Good relational and communicative skills at all organizational levels, in local and international context.
- Good ability to identify problems and propose solutions.
- Adherence to the Grifols skills and values.
LANGUAGES
Fluent English and Arabic language.
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.
