Job Description
Roles & Responsibilities
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.
Desired Candidate Profile
- Bachelors Degree in Health-related Sciences.
- Knowledge in Quality Management.
- Strong integrity and commitment to quality and compliance.
- MS Office knowledge
- 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.
- Written and spoken English and Arabic.