Job Description

Roles & Responsibilities

Job Title: Center Quality Assurance Specialist

Department /Sub-Department: Center Quality Assurance

Direct Manager: Center Quality Manager

Workplace: Plasma Center

Job Objective

One sentence summary of the main objective of the job, the most important activities and the means and guidelines to obtain the objectives.

To perform Quality Assurance functions to ensure compliance with internal and external regulationsand protocol under the direct supervision of the Center Quality Manager (CQM).To edit SOP's related to processes at donor center level following the guidelines established according to Egyptian regulations and the guidelines established according to cMP requirements.

Environment

Internal and external interactions i.e.: with other departments/divisions, international scope, providers, customers)

Internal: Grifols Egypt for Plasma Derivatives (GEPD)plasma general management, especially the Director of quality, quality department of other GEPD plasma donor centers (DC).

External: Donors, Health Authorities, government agencies.

Key responsibility

• To perform periodical review of DC records.
• To perform periodical equipment quality control review.
• To perform periodical review of equipment incident logs.
• To verify and release of sample shipments.
• To inspect and release of incoming supplies.
• To perform periodical employee observations.
• To assist to CQM to ensure cGMP regulations are followed.
• To assist to CQM to ensure that SOP's are followed.
• To assist to CQM in the edition of SOP's.
• To perform a review of the documentation of unsuitable test results and the disposition of the associated units.

Performs a higher-level document review and employee observations. Ability to work in groups and with other departments.

Communicates openly with CQM on issues noted during reviews and is able to give suggestions for corrections.

Has a good understanding of cGMP and quality systems.

Good ability to identify problems and propose solutions.

Adherence to the Grifols skills and values.

Desired Candidate Profile

Academic experience required

Bachelor's Degree in Health-related Sciences. Knowledge in Quality Management. Strong integrity and commitment to quality and compliance.

Professional Experience Required

Preferably at least 2 years of experience in a similar position, in environments of Good Manufacturing Practices (GMP) and Pharma background.

Computing Skills

Ms Office knowledge.

Personal Skills

Ability to understand, explain, follow and enforce SOPs, protocols and other regulatory guidelines. Ability and willingness to study specific activities, in a short time. Accuracy and reliability. Can work independently, excellent organizational skills, and attention to detail.

Languages

Written and spoken English and Arabic.