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Center Quality Assurance Specialist

Grifols Egypt for Plasma Derivatives
Cairo, Egypt
Posted 3 months ago
198Applicants for2 open positions
  • 31Viewed
  • 22In Consideration
  • 0Not Selected
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Job Details

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Job Description

• 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 SOP’s 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 SOP’s are followed.

 • To assist to CQM in the edition of SOP’s. To perform a review of the documentation of unsuitable test results and the disposition of the associated units
 

Job Requirements

• Bachelor’s Degree in Health-related Sciences. 

• Knowledge in Quality Management 

• Strong integrity and commitment to quality and compliance

• Preferably at least 2 years of experience in a similar position, in environments of Good Manufacturing Practices (GMP) and Pharma background.

• 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.

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