Grifols Egypt for Plasma Derivatives→

Center Quality Assurance Specialist (Helwan) at Grifols Egypt… · Cairo

Mid LevelOn-siteFull-timeCairo, Cairo, Egypt

Skills

cgmpgmpquality managementms officeintegritycommitment to qualityattention to detailorganizational skillscommunicationproblem solvingability to work independentlyteamwork

Job 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

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.