Medical Device Auditor 3

Profile: 20 Pharma Audits per year: Clinical (25%) Raw Mat. (25%), Pack Mat (25%), Finished (25%) . 10 Medical Devices audits per year (e.g. Syringes, Intravenous Bags, Implants, Distribution) . 1-2 Consultancies per year in Supplier Quality Management, Remediation, Inspection, QMS. Skiils include GCP, GVP, GMP, GDP, Auditing, Quality Assurance, System, Management, Regulatory Requirements Affairs, FDA, EU, PV ADR Pharmacovigilance, Manufacturing, Clinical Trials, Monitoring, Selection, Medical Devices, Pharmaceuticals, Biotechnology, Sterile, Asceptic, Biologicals, ATMP, Laboratory, Quality Control, Remediation, Inspection Preparation, QMS SOP, Gap Analysis, Combination Products, Pharmacovigilance, Complaints, Supply Chain, Distribution, Transportation, Logistics, Quality Agreements, Sub-contractors, Regulations, Risk Management, CAPA, ISO, Deviations, Change Control, Root Cause Analysis, Investigational Medicines, Supply Chain, ICH, Validation, GAMP5, Data Integrity, Process Improvement, Training, Documents, Clinical. Countries Covered: Italy (Milan, Rome, Naples, Calabria, Sicily, Sardinia) Germany, France Netherlands, Belgium, Luxembourg,Ireland, Denmark, Finland,Bulgaria, Hungary, Romania, Croatia,Malta, Greece, Cyprus, Spain, Portugal,UK, Switzerland,Turkey, Israel ,USA, Brazil, Australia. Language Expertise: English: Mother tongue,Italian: Professional,Dutch: Intermediate,French: Basic / Intermediate,Maltese: Mother tongue. Current Location: Malta.