Plasma Center Operations Manager

2 days ago

مصر, Egypt 00E1 - Grifols Egypt Plasma Der Full time

¿Quieres unirte a un equipo internacional que trabaja para mejorar el futuro del sector de la salud? ¿Quieres mejorar la vida de millones de personas? Grifols es una compañía global del sector de la salud que, desde su fundación en Barcelona en 1909, trabaja para mejorar la salud y el bienestar de las personas en todo del mundo. Nuestras cuatro divisiones -Bioscience, Diagnostic, Hospital y Bio Supplies
- desarrollan, producen y comercializan medicamentos, soluciones y servicios innovadores en más de 100 países y regiones.

**JOB OBJECTIVE**

To ensure the correct implementation of Standard Operating Procedures (SOP’s) 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.

**ENVIRONMENT**

Internal: Manufacturing, Quality global, Supply Chain, Administration & Services divisions, and Grifols Egypt for Plasma Derivatives plasma general management.

External: donors, Health Authorities, groups, business service providers, auditors, and community and neighborhood organizations.

**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 mínimal 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.
- #LI-LS1_

**Ubicación**:EMEA : Egypt : Egypt**:EGTOLIP - Tolip El Narges-New Cairo**

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