To perform Quality Assurance functions to ensure compliance with internal and external regulations and protocol under the direct supervision of the Center Quality Manager (CQM).
To edit SOPs related to processes at donor center level following the guidelines established according to Egyptian regulations and the guidelines established according to cGMP requirements.
KEY RESPONSIBILITIES
To perform periodical review of DC records.
To perform periodical equipment quality control review.
To perform periodical review of equipment incident logs.
To verify and release of sample shipments.
To inspect and release of incoming supplies.
To perform periodical employee observations.
To assist to CQM to ensure cGMP regulations are followed.
To assist to CQM to ensure that SOPs are followed.
To assist to CQM in the edition of SOPs. To perform a review of the documentation of unsuitable test results and the disposition of the associated units
Bachelors Degree in Health-related Sciences.
Knowledge in Quality Management
Strong integrity and commitment to quality and compliance
Preferably at least 2 years of experience in a similar position, in environments of Good Manufacturing Practices (GMP) and Pharma background.
MS Office knowledge
Ability to understand, explain, follow and enforce SOPs, protocols and other regulatory guidelines.
Ability and willingness to study specific activities, in a short time.
Accuracy and reliability.
Can work independently, excellent organizational skills, and attention to detail.
Performs a higher-level document review and employee observations
Ability to work in groups and with other departments.
Communicates openly with CQM on issues noted during reviews and is able to give suggestions for corrections. Has a good understanding of cGMP and quality systems.
Good ability to identify problems and propose solutions. Adherence to the Grifols skills and values.
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.
