Responsibilities
- To direct and monitor processes and to ensure DC compliance with Egyptian Regulations and company- designated regulations.
- To collaborate with Center Manager to ensure product quality, donor suitability and donor safety.
- To ensure that SOPs are properly interpreted, implemented in a timely fashion, and that the staff performs according to all SOPs.
- To interpret and implement 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, review of and preparation 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 personnel functions of the Quality Plasma center Specialist(s)
- Oversees product and biohazard waste shipments: Ensures shipments meet regulatory specifications and product release requirements; ensures accurate labeling and documentation; and, authorizes final shipment.
- To perform a review of the documentation of unsuitable test results and the disposition of the associated results.
- To document, investigate, and perform root cause analysis for deviations and customer complaints, specifically in how they relate to the safety of the donor and the quality of the product.
Qualifications :
- B.S. degree, preferably in a health-related science.
- Preferably Post- Graduate Certification in Quality Management
- 2 years of Experience on Quality system tasks desired
- Supervisory experience preferred. Experience in a medical and/or cGMP regulated environment preferred.
- Experience with plasma or whole blood preferred.
- Ensures that job and Current Good Manufacturing Practice (cGMP) training is completed, documented, and on file.
- Partners with the Center Manager to determine donor suitability activities and manages donor deferrals as appropriate
- Reviews and approves of deferred donor reinstatement activities
- Performs a review of lookback information
- Reporting center quality status to plasma QA senior Manager to provide additional oversight and guidance.
- Tracks/Trends and performs follow-up on corrective and preventative actions, system implementations, and process improvement plans to measure/determine effectiveness. Makes adjustments where required