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QA Compliance Specialist

MEVAC - Facility ( El-Salhya El-Gedida)Quality Assuranceمن مقر العمل
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الوصف الوظيفي

The role focuses on maintaining compliance through rigorous documentation, audit preparation, deviation management (CAPA), and staff training, ultimately minimizing risk and driving continuous improvement in quality processes.

المسؤوليات

Regulatory Compliance

  • Ensure adherence to ISO, EU GMP, WHO, and PIC/S guidelines.
  • Monitor compliance with internal SOPs, quality policies, and QMS requirements.

Documentation & Systems

  • Review and approve SOPs, protocols, and change controls.
  • Maintain compliance records in TrackWise or equivalent e-QMS platforms.

Audit & Inspection Readiness

  • Prepare for internal and external audits (ISO 9001, ISO 14001, ISO 45001, ISO 50001, ISO 17025).
  • Support mock inspections and CAPA implementation.

Risk & Deviation Management

  • Investigate deviations, non-conformities, and complaints.
  • Perform root cause analysis and implement corrective/preventive actions.

Training & Awareness

  • Conduct compliance training for staff on GMP and QMS requirements.
  • Ensure retraining after SOP updates or process changes.

Continuous Improvement

  • Participate in quality councils and improvement projects (Lean, Six Sigma).
  • Monitor compliance KPIs and report trends to management.

Education:

المتطلبات

  • Bachelor’s degree in science or Veterinary Medicine.
  • 1-3 years of experience in the pharmaceutical/vaccine industry.
  • Courses in Quality Management are a plus.
  • Good in English (written and spokCorrective & Preventive Actions (CAPA)en)

المزايا

  • Social, Medical and Life Insurance
  • Pension Coverage
  • Profit Share
  • Quarterly Balanced Scorecard
  • Transportation from certain points
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