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Center Quality Manager – Ain Shams

Grifols Egypt for Plasma Derivatives (GEPD) · Ain Shams

Mid 🇬🇧 English
Root cause analysis

Job description

About the role

The Center Quality Manager ensures that the donor center operates in full compliance with local, national and international regulations while maintaining the highest standards of product quality, donor suitability and safety.

Key responsibilities

  • Maintain compliance with all regulatory requirements and SOPs, collaborating with Center and Operations Management.
  • Interpret, implement and modify quality control processes, SOPs and regulatory guidelines.
  • Lead internal and external audits, including documentation, preparation and response review.
  • Continuously improve the quality system by analysing trends, investigating failures and reviewing documentation.
  • Oversee training, development and performance of Center Quality Specialists.
  • Manage product and bio‑hazard waste shipments, ensuring regulatory specifications, labeling and documentation.
  • Document, investigate and conduct root‑cause analysis for deviations and customer complaints.
  • Ensure staff are up‑to‑date with current cGMP training and maintain training records.
  • Assist Center Manager with donor suitability decisions, deferrals and reinstatements.
  • Report quality status to the Regional Quality Manager.

Required profile

  • B.S. in a health‑related science (preferably Pharmacy); post‑graduate certification in Quality Management is a plus.
  • Minimum 2 years of Quality Assurance experience, including managerial responsibilities.
  • Experience in a CGMP‑regulated, pharmaceutical environment.
  • Proficient computer skills and ability to understand and enforce SOPs and regulatory guidelines.
  • Strong analytical abilities for root‑cause analysis and corrective/preventive actions.
  • Excellent written and spoken English and Arabic.

Required skills

  • Root cause analysis
  • Computer proficiency

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Published 3 months ago

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Grifols Egypt for Plasma Derivatives (GEPD)

Ain Shams