B 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

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.

- 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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