Qualified Person - Quality Assurance Manager
Since February 2013
Qualified Person / Quality Assurance Manager Radiopharmaceutical Industry Quality System Control cGMP Knowledge of EU-cGMP Production and Quality Controllo of radiotracers fluorurate, technetium and gallium-68 DOTATOC (Edotreotide) Labelling of biologically active macromolecules for PET / SPECT / MRI / NIR for diagnosis of cancer and inflammatory diseases. Preparazione anche Verificati in of: Factory Acceptance Test (FAT), Site Acceptance Test (SAT), Installation/Instrument Qualification (IQ), Operations Qualification (OQ), Process Validation (PV), Performance Qualification (PQ), Design Qualification (DQ), Risk Analysis e Risk Assessment, Validation Master Plan, Site Master File, Drug Master File, IMPD, SOP, URS.
Radiopharmacist - Quality Assurance Manager
July 2011 --- January 2013
Quality System Controllo Management for "Norme di Buona Preparazione dei radiofarmaci" (F.U.I. ed. XII) Production anche Quality Controllo of 2-18F-2-deoxy-D-glucopyranose Cell's radiolabelling.
Biochemistry Lab scale batches R&D21 CFR Part 11Analytical ChemistryAnalytical Method ValidationAntibodiesBacteriologyBiomarkersCAPAcGMPChange ManagementChange ControlChromatographyCleaning ValidationCurrent Good Manufacturing Practice (CGMP)FDAgas chromatographyGalenicsGood Manufacturing Practice (GMP)GXPHPLCIMPDInstrument Validation ProtocolsIsotope SynthesisLC-MSMicrosoft ExcelMicrosoft OfficeMicrosoft PowerpointMicrosoft WordNuclear radiology NMROrganic ChemistryQA complianceQuality Assurance (QA)Quality AuditingQuality Control (QC)Quality Management System (QMS)RadiologyRoot Cause Analysis (RCA)Six SigmaStandard Operating Procedure (SOP)SterilizationVeterinary MedicineWriting Study Procedures and SOPs
Skills and Expertise
Create SOPs Assure medical quality Molecular Diagnostics Write protocolsApprove drug supply Archive documentationAseptic processingBiomarker ResearchDevelop ICH/GCP compliant processesDevelop Quality Risk Management (QRM) initiativesDevelopment of late-stage cGMP production processesImplement Quality Management System (QMS)Maintain Quality Management System (QMS)Manage Quality Management System (QMS) documentationManufacture of GMP batchesManufacture of non-GMP and GMP batchesR&DQuality testing of Investigational Medicinal Products (IMPs)
Biology in Biology/Biological Science from Università degli Studi di Napoli 'Federico II' in 2015
Veterinary Medicine in Veterinary Medicine from Università degli Studi di Napoli 'Federico II' in 2014
Pharmaceutical Chemistry and Technology in Pharmaceutical Chemistry and Technology from Università degli Studi di Napoli 'Federico II' in 2010
Training and Certification
Auditor/Lead Auditor for Quality System Control ISO 9001:2008 Certification
Qualified Person (art. 52 of D.lgs 24 april 2006, n. 219) Certification