Center Quality Assurance Specialist (Helwan)

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.