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.
Academic Experience required:
B.S. degree in health-related science, preferably in Pharmacy.
Post-graduate certification in Quality Management preferred.
Professional Experience Required:
2 years of experience in Quality Assurance, with managerial experience.
Experience in a cGMP regulated environment, Pharmaceutical background preferred.
Computing Skills:
Proficient in computer skills.
Personal Skills:
Ability to understand and assess relevant regulations.
Ability to understand, explain, follow, and enforce SOPs, protocol and other regulatory guidelines.
Proficient in root cause analysis and corrective/preventative actions
Ability to balance multiple competing priorities
Strong time management abilities
Ability to work with minimal supervision
Accuracy and reliability.
Ability to work in groups and with other departments.
Adherence to the Grifols skills and values.
Languages:
Excellent written and spoken English and Arabic.
