Center Quality Assurance Specialist
4 weeks ago
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.
**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.
LI-LS1
**Location**:EMEA : Egypt : Egypt**:EGTOLIP - Tolip El Narges-New Cairo**
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