JOB OBJECTIVE
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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).
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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
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To perform periodical review of DC records.
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To perform periodical equipment quality control review.
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To perform periodical review of equipment incident logs.
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To verify and release of sample shipments.
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To inspect and release of incoming supplies.
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To perform periodical employee observations.
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To assist to CQM to ensure cGMP regulations are followed.
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To assist to CQM to ensure that SOPs are followed.
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To assist to CQM in the edition of SOPs.
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To perform a review of the documentation of unsuitable test results and the disposition of the associated units.
Academic Experience Required
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Bachelors Degree in Health-related Sciences.
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Knowledge in Quality Management.
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Strong integrity and commitment to quality and compliance.
Computing Skills
MS Office knowledge
Personal Skills
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Ability to understand, explain, follow and enforce SOPs, protocols and other regulatory guidelines.
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Ability and willingness to study specific activities, in a short time.
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Accuracy and reliability.
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Can work independently, excellent organizational skills, and attention to detail.
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Performs a higher-level document review and employee observations
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Ability to work in groups and with other departments.
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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.
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Good ability to identify problems and propose solutions.
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Adherence to the Grifols skills and values.
LANGUAGES
Written and spoken English and Arabic.