Inspector – Good Practices (GxP)
Emirates Drug Establishment مؤسسة الإمارات للدواء · Doubaï
Job description
About the role
Emirates Drug Establishment is hiring experienced regulatory inspectors to strengthen its Good Practices inspection capability across pharmaceutical, biological and medical-product operations. The role suits specialists with inspection, auditing or manufacturing experience in areas such as biologics, sterile pharmaceuticals, pharmaceutical engineering, computerised systems and GCP.
Key responsibilities
- Plan and conduct risk-based GxP inspections, audits and follow-up activities.
- Assess compliance with applicable UAE requirements and internationally recognised standards, including PIC/S guidance where relevant.
- Review facilities, quality systems, manufacturing operations, computerised systems, validation, engineering controls and corrective-action plans.
- Prepare clear inspection reports, identify compliance gaps and recommend regulatory actions.
- Support the development of inspection procedures, technical guidance and inspector capability.
Required profile
- Bachelor's or Master's degree in Pharmacy, Pharmaceutical Sciences, Biotechnology, Biomedical Engineering, Chemical/Pharmaceutical Engineering, IT/Software Engineering or a related discipline.
- Strong experience in pharmaceutical, biologics, ATMP, sterile-product, clinical-research, medical-device or regulatory inspection environments.
- Practical knowledge of GMP, GDP, GCP, GAMP 5 and other applicable GxP standards.
- Formal auditor/inspector certification preferred; GCP auditor certification required for the GCP specialism.
- PIC/S exposure strongly preferred.
- Excellent report-writing, stakeholder-management and professional English; Arabic is an advantage.
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Published 3 hours ago
Expires 1 month from now
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Emirates Drug Establishment مؤسسة الإمارات للدواء
Doubaï