Center Quality Assurance Specialist… at Grifols Egypt… · Zagazig

JOB OBJECTIVE - To perform Quality Assurance functions to ensure compliance with internal and external regulations and protocol under the direct supervision of the Center Quality Manager (CQM).

• To edit SOPs related to processes at donor center level following the guidelines established according to Egyptian regulations and the guidelines established according to cGMP requirements.

KEY RESPONSIBILITIES - 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 SOPs are followed.
• To assist to CQM in the edition of SOPs.
• To perform a review of the documentation of unsuitable test results and the disposition of the associated units.

ACADEMIC EXPERIENCE REQUIRED

• Bachelors Degree in Health-related Sciences.
• Knowledge in Quality Management.
• Strong integrity and commitment to quality and compliance.

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.
• 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.

LANGUAGES Written and spoken English and Arabic.