Center Quality Assurance Specialist (EGYPT) - Suez
Egypt, EG
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Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. |
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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 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.
ENVIRONMENT
Internal: Grifols Egypt for Plasma Derivatives (GEPD)plasma general management, especially the Director of quality, quality department of other GEPD plasma donor centers (DC)
External: Donors, Health Authorities, government agencies.
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
ACADEMIC EXPERIENCE REQUIRED
• Bachelor’s 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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Location: EMEA : Egypt : Egypt:EGTOLIP - Tolip El Narges-New Cairo