Dublin, County Dublin, Ireland
Quality Assurance SME with over 8 years of experience in the pharmaceutical and biotech sectors, specializing in supplier and material compliance, external manufacturing oversight, and regulatory audit readiness within GMP regulated environments. Areas of expertise include: - Supplier qualification and external entity management (GMP/GDP) - QA QC - QA V - Change control, CAPA and root cause analysis - Regulatory inspection support (HPRA, FDA, EMA) - Quality systems implementation and KPI monitoring - Leadership of cross-functional teams and continuous improvement initiatives At MSD, I lead QA operations supporting global supply chains and key strategic initiatives, including Shared Services Programs, product technical transfers, and warehouse QA oversight. I act as Subject Matter Expert during regulatory inspections and support site compliance through system development and deviation management. Fluent in English and Italian. Based in Dublin. Focused on continuous improvement, cross functional collaboration, and delivering value through quality and compliance in regulated environments.
External Entity Management. Incoming material qualification and release. Quality Assurance for warehouse, dispensing and supply chain activities.
• Customer Service • Supplier Management • Regulatory Compliance • Documentation, and accounts management • Employees management