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Center Quality Assurance Specialist (Helwan)

Grifols Egypt For Plasma Derivatives

Le Caire, Egypt1 month ago
58 views19 saves2 applies

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Job Type

full time

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.

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Skills

quality managementdocument reviewquality assurancequality control

About Grifols Egypt For Plasma Derivatives

Grifols Egypt for Plasma Derivatives (GEPD) is a joint-venture between the Egyptian Government and Grifols, dedicated to enhancing the health and well-being of Egyptians by providing access to safe and high-quality lifesaving medicines derived from human plasma.

biotechnology, pharmaceuticalsWebsite