Center Quality Manager

Grifols Egypt for Plasma Derivatives

Job Description:

• Ensures that the donor center remains compliant with local, national, and international regulations.
• Collaborate with Center Management to ensure product quality, donor suitability, and donor safety.
• Ensures timely implementation and support center understanding of SOPs.
• Works with Operations Management to ensure ongoing center compliance with SOPs.
• Interprets and implements processes, regulations, and SOPs for quality control and overall regulatory compliance, making independent decisions and modifications, as required.
• Oversight of all aspects of internal and external audits including execution, if applicable.
• This includes documentation, preparation, and review of the response.
• Continuously assesses, promotes, and improves the effectiveness of the quality systems in the DC through recognition of trends, investigation of failures in the execution of procedures, direct employee observation, and review of center documents.
• Responsible for the direct oversight of the Center Quality Specialist(s) training, development, activities, and performance.
• Oversees product and biohazard waste shipments. Ensures that product shipments meet regulatory specifications and product release requirements, ensures accurate labeling and documentation, and authorizes final shipment.
• Performs a review of the documentation of unsuitable test results and the disposition of the associated units.
• Documents, investigates, and conducts root cause analysis for deviations and customer complaints, particularly concerning donor safety and product quality.
• Ensures that the DC staff remains up to date on current Good Manufacturing Practice (cGMP) training and that trainings are properly documented and on file.
• Cooperates with the Center Manager to make donor suitability decisions and to manage donor deferrals.
• Reviews and approves deferred donor reinstatements.
• Performs a review of lookback information.
• Reports center quality status to the Regional Quality Manager so the RQM can provide additional oversight and guidance.