Job Description

JOB OBJECTIVE

To ensure the correct implementation of Standard Operating Procedures (SOPs) in plasma center following the guidelines established

To evaluate processes, develop action plans, and coordinate the strategic implementation of system processes and corrective actions in order to ensure product quality, donor suitability and donor safety.

This position is rotational shifts not fixed , 8 working hours , 5 working days

KEY RESPONSIBILITIES

• To Direct and monitor processes and to ensure center 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 donor center 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.
• Review the QA reports for timely and appropriate actions on moderate complexity procedures for test problems
• 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.
• 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. Learn, understand and be independent working with the PDS (Plasma Donor system) as it relates to the duties and responsibilities of this position.

ACADEMIC EXPERIENCE REQUIRED

B.S. degree, preferably in a health-related science. Preferably Post-Graduate Certification in Quality Management

PROFESSIONAL EXPERIENCE REQUIRED

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.

COMPUTING SKILLS

Proficiency in Computers

PERSONAL SKILLS

• Ability to understand and assess relevant regulations.
• Ability to understand, explain, follow and enforce SOPs, protocols 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

Written and spoken English and Arabic.