The In-Process Quality Specialist is responsible for executing and monitoring all in-process quality
controls during manufacturing operations to ensure product quality, compliance with cGMP
activities which directly or indirectly impact the quality of the product manufactured in GEPD New
Capital Manufacturing site.
Environment
Internal and external interactions i.e.: with other departments/divisions, international scope,
providers, customers)
Internal: GEPD Manufacturing site teams, Quality System Team, Operations, and other
supportive functions.
External: In absence of the In-Process Quality Manager, Auditors and Health Authorities.
Key responsibility
Perform in-process checks, sampling, and testing in accordance with approved procedures and
regulatory guidelines.
Ensure proper use, handling, cleaning, and segregation of sampling equipment to prevent
cross-contamination.
Conduct regular GEMBA and shop-floor walkthroughs to verify compliance with GMP,
GEPD, and IPC requirements.
Review and verify IPC records, batch data, critical parameters, and equipment logs for
accuracy and compliance.
Support the implementation and maintenance of the Contamination Control Strategy (CCS)
by following defined controls, identifying gaps, and reporting risks related to contamination
prevention.
Ensure timely and accurate IPC documentation and support batch record completion to enable
batch release readiness.
Monitor IPC results, identify deviations, atypical events, or trends, and escalate further
investigation.
Support implementation and improvement of IPC procedures and cross-contamination control
practices (cleaning, validation, and use of dedicated or disposable equipment).
Coordinate with production to ensure adherence to IPC frequencies and availability of required
materials and equipment.
Academic experience required
Bachelor's degree in health-related Sciences, preferably as a pharmacist.
Knowledge of cGMP requirements, aseptic processing and in-process Quality Control.
Professional experience required
Minimum 2-3 years of experience in similar position at GMP pharmaceutical manufacturing,
with aseptic operations.
Computing skills
Proficiency in computer, MS Office knowledge.
Experience with eQMS and ERP systems.
Personal skills
Organized and able to manage time effectively.
Ability to work within a highly regulated, labor-intensive environment.
Ability to understand, explain, follow, and enforce SOPs.
Organizational and problem-solving skills.
Strong integrity and commitment to Quality and Compliance.
Ability to work in groups and with other departments.
Excellent oral and written communication skills to produce clear and concise factual findings.
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.
