GxP Inspector: GMP, GCP & Biologics

Emirates Drug Establishment مؤسسة الإمارات للدواء; Dubai; Sur place; AED 120 000 - 180 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Inspection expertise

Regulatory knowledge

Report writing

Stakeholder management

English communication

Formation

Bachelor's or Master's in relevant field

Description du poste

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.