Center Quality Assurance Specialist

2 days ago

Giza, Giza, Egypt Grifols Egypt for Plasma Derivatives Full time

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.

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