Center Quality Specialist - October

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. 

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 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

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.

Good ability to identify problems and propose solutions.
Adherence to the Grifols skills and values. 

LANGUAGES :

Written and spoken English and Arabic.