✨ AI Summary
The Center Quality Assurance Specialist in Menoufia will perform Quality Assurance functions to ensure compliance with internal and external regulations and protocols, reporting to the Center Quality Manager. Key responsibilities include reviewing donor center records, equipment quality control, incident logs, sample shipments, and incoming supplies. The role also involves conducting employee observations, assisting the CQM in ensuring cGMP and SOP adherence, and aiding in SOP edition. A Bachelor's Degree in Health-related Sciences, knowledge in Quality Management, and strong integrity are required. Proficiency in MS Office and strong interpersonal skills, including the ability to work independently and in teams, are essential. Written and spoken English and Arabic are necessary.
Requirements
Requires a Bachelor's Degree in Health-related Sciences and knowledge in Quality Management. Must possess strong integrity and commitment to quality and compliance. Proficiency in MS Office is necessary. The role involves understanding, explaining, following, and enforcing SOPs, protocols, and regulatory guidelines, with the ability to study specific activities quickly. Accuracy, reliability, and the ability to work independently with excellent organizational skills and attention to detail are crucial. The candidate should be able to perform higher-level document reviews and employee observations, work in groups with other departments, communicate openly with the Center Quality Manager on issues, and propose solutions for identified problems.
Description
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 SkillsMS Office knowledgePersonal 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.LANGUAGESWritten and spoken English and Arabic.