-Supplier Qualification Manager will perform technical management and supervision of the audits performed to critical suppliers, as well as will evaluate the KPIs (Key Process Indicators) established to assess the level compliance to cGMP of their products or services.
Key responsibility
· Establish a defined suppliers qualification process following the guidelines according to Egyptian regulations and cGMP requirements.
· Manage a system of a global qualification process of suppliers, considering KPIs and audit performance results that will ensure the correct evolvement of suppliers.
· Work closely with purchasing managers, end-users and suppliers to resolve compliance issues and problems as part of risk management activities.
· Review and perform supplier evaluations and root cause investigations to implement corrective actions on raw materials and contracted services.
· Review, evaluate and follow-up on all supplier corrective action requests.
· Supervise and maintain Quality Agreements with critical suppliers.
· Support regulatory inspections received by Health Authorities.
· Provide guidance to Supplier Qualification specialist under his/her responsibility.
Academic experience required
· Bachelor s Degree in Health-related Sciences.
· Post-Graduate Certification in Quality Management.
· Knowledge of cGMP requirements.
Professional experience required
· Minimum of 2 years of Management or technical leadership experience is required.
· Minimum of 6 years of related experience in Suppliers Qualification field in Pharmaceutical company.
Computing skills
MS Office knowledge.
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 and protocols.
· Ability to plan, communicate and execute activities for the improvement of overall operations.
· 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 and ability to present effectively to groups.
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.
