Center Quality Assurance Specialist

4 days ago

Al Mansurah, Dakahlia, Egypt Grifols Egypt for Plasma Derivatives (GEPD) Full time

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

  • 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.

  • 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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