BrightOwl Loader Loading

Summary

• I am a Qualified Person (art. 52 of Legislative Decree 24 April 2006, n. 219) • I have a strong experience in the Pharmaceutical Industry, in particular in cGMP, GLP and CFR21 parte 11 • Preparation and Verification 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 and Risk Assessment, FMEA/FMECA, Validation Master Plan, Site Master File, Drug Master File, IMPD, SOP, URS • I am an Auditor/Lead Auditor ISO 9001:2015, ISO\IEC 17025:2005, ISO 14001:2015, OHSAS 18001:2008. • I worked for many years with success in the field of research (radiotracer's development, nanoparticles, multimodal tracers, labelling of biologically active macromolecules for PET / SPECT / MRI / NIR for diagnosis of cancer and inflammatory diseases, etc...)

Experiences

Current Experience

  • 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.

Past Experience

  • 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.

Personality

Self Assessment :
AdaptabilityAnalytical thinkingCollaborationCoordinationEfficiency

Knowledge

Self Assessment :
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
LinkedIn Assessment :
FDA GMPSistema di qualitàFailure Mode and Effect Analysis (FMEA)21 CFR Part 11SOPConvalidaRegulatory affairsChange ControlVerifica e validazioneAzioni correttive e preventiveRoot Cause AnalysisRadiochimicaFDAISO 9000ISO 9001ISO 17025ISO 22000ISO 14001Controllo della qualitàHPLCGC-MSICH-GCPTecniche estrattivePurificazioneHACCPSintesi organicaIndustria FarmacéuticaChimica analiticaChimica farmaceuticaChimica organicaMedicina nucleareControllo qualitàMedicina veterinariaSicurezza alimentareIndustria alimentareTecnologia alimentareNorme di buona fabbricazioneFarmacologiaStrumenti medicaliScienze naturaliTossicologiaBiochimicaChimicaBuona pratica di laboratorioGestione qualitàRicerca e sviluppoTrasferimento tecnologicoSperimentazioni clinicheSterilizationLaboratorio

Skills and Expertise

Self Assessment :
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)

Education

  • 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

Languages

BrightOwl Assessment:
Self Assessment:
Italian
Native
English
Professional Proficiency

Work Preferences

  • Notice Period:
    12 weeks
  • Positions I am interested in:
    Quality Assurance (QA) Manager QC/QA Manager Qualified Person Quality manager
  • Locations I am interested in:
    Naples, Metropolitan City of Naples, Italy
  • Work From Home:
    No
  • Work Regime:
    Permanent position
  • International:
    Yes

Area / Region

Naples, Italy

Others

Driving License
  • Yes