Inspector – Good Practices (GxP)
Emirates Drug Establishment مؤسسة الإمارات للدواء · Dubai, United Arab Emirates
Tailor my CV for this job — freeWe Are Hiring | Expert Inspector – Good Practices (GxP)Location: UAESector: Licensing & Control / InspectionEmirates 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) manufacturingSterile pharmaceutical manufacturingPharmaceutical engineering, including HVAC and cleanroom systemsComputerised systems, GAMP 5, IT and software engineeringGood Clinical Practice (GCP), with recognised regulatory-auditor certificationBiomedical engineering and medical-device-related GxP inspectionKey ResponsibilitiesPlan 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 & ExperienceBachelor’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.#Hiring #Inspector #GMP #GxP #PICs #Biologics #ATMP #SterileManufacturing #GAMP5 #GCP #PharmaceuticalEngineering #BiomedicalEngineering #UAEJobs #EmiratesDrugEstablishment