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Center Quality Assurance Specialist

2 weeks ago

Suez, Suez, Egypt Grifols Egypt for Plasma Derivatives (GEPD) Full time 30,000 - 60,000 per year

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.

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.