Inspector – Good Practices (GxP)

Emirates Drug Establishment مؤسسة الإمارات للدواء; Dubai; On-site; AED 120,000 - 180,000; Full time

Job summary

Emirates Drug Establishment in the UAE is seeking an Expert Inspector with strong GxP inspection, auditing and manufacturing experience to strengthen its licensing and control functions across pharma, biologics and medical-device operations.

The role involves planning and conducting risk-based inspections, reviewing facilities and quality systems, preparing clear reports and supporting procedures development. Fluency in English is essential; Arabic is an advantage.

Qualifications

• Experience in pharmaceutical, biologics, ATMP, sterile-product, clinical-research, or medical-device inspections.
• GMP, GDP, GCP, GAMP 5 and other applicable GxP standards familiarity.
• Formal auditor/inspector certification preferred; GCP auditor certification required for the GCP specialism.
• Arabic language is an advantage.

Responsibilities

• Plan and conduct risk-based GxP inspections, audits and follow-up activities.
• Assess compliance with UAE requirements and international standards (PIC/S where relevant).
• Review facilities, quality systems, manufacturing operations, computerised systems, validation, engineering controls and CAPAs.
• Prepare clear inspection reports, identify gaps and recommend regulatory actions.
• Support development of inspection procedures, technical guidance and inspector capability.

Skills

Inspection expertise

Regulatory knowledge

Report writing

Stakeholder management

English communication

Education

Bachelor's or Master's in relevant field

Job description

We Are Hiring | Expert Inspector – Good Practices (GxP)

Location: UAE

Sector: Licensing & Control / Inspection

Emirates Drug Establishment is seeking experienced regulatory inspectors to strengthen its Good Practices inspection capability across pharmaceutical, biological and medical-product operations.

We are looking for specialists with demonstrated inspection, auditing or manufacturing experience in one or more of the following areas:

• Biologics and Advanced Therapy Medicinal Products (ATMPs) manufacturing
• Sterile pharmaceutical manufacturing
• Pharmaceutical engineering, including HVAC and cleanroom systems
• Computerised systems, GAMP 5, IT and software engineering
• Good Clinical Practice (GCP), with recognised regulatory-auditor certification
• Biomedical engineering and medical-device-related GxP inspection

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 appropriate regulatory actions.
• Support the development of inspection procedures, technical guidance and inspector capability.

Qualifications & Experience

• Bachelor’s or Master’s degree in Pharmacy, Pharmaceutical Sciences, Biotechnology, Biomedical Engineering, Chemical/Pharmaceutical Engineering, IT/Software Engineering, or a related discipline.
• Strong relevant 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 is preferred; GCP auditor certification is required for the GCP specialism.
• Exposure to PIC/S inspection principles and requirements is strongly preferred.
• Excellent report-writing, stakeholder-management and professional English communication skills. Arabic is an advantage.

If you have the technical depth and regulatory judgement to help safeguard the quality, safety and compliance of regulated health products, we welcome your application.

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