COMPUTER SYSTEM VALIDATION

4 settimane fa


verona, Italia Orienta Filiale di Verona A tempo pieno

Orienta Spa, Società Benefit filiale di Verona, ricerca per realtà di consulenzaCOMPUTER SYSTEM VALIDATION & DATA INTEGRITY CONSULTANT – GxPLa figura lavorerà su progetti di validazione e compliance che coinvolgono processi GxP (GMP, GCP, GLP, GVP), supportando aziende farmaceutiche, CRO, dispositivi medici e strutture sanitarie.Attività previste:Analisi dei requisiti regolatori GxP per sistemi computerizzati e piattaforme digitaliRedazione di Validation Master Plan e documentazione end-to-end (URS, RA, IQ/OQ/PQ)Validazione di sistemi applicativi (LIMS, ERP, eQMS, MES, eTMF, strumenti di laboratorio)Implementazione delle strategie di Data Integrity e definizione di controlli tecnici/proceduraliSupporto a Audit GxP interni ed esterniGestione di change control, deviazioni, incident e CAPA su applicativi e infrastrutture ITTraining agli utenti finali sulle procedure di compliance e DIRequisitiLaurea in discipline scientifiche o ingegneristicheEsperienza nel ruolo CSV in contesti multi-GxPConoscenza delle linee guida internazionali (GAMP 5, FDA, EMA, WHO Data Integrity)Familiarità con architetture IT, applicativi enterprise e sistemi di laboratorioBuona padronanza della lingua ingleseSoft SkillsAdattabilità a contesti diversi (QC, QA, Clinical, Engineering, IT)Capacità organizzativa e gestione di più progettiProattività, precisione e orientamento alla qualitàComunicazione efficace e capacità di relazione con il clienteSi propone:Inserimento diretto in aziendaCCNL applicato: Chimica Industria * 13 mensilitàOrario di lavoro: Full-time 40 ore dal lunedì al venerdì.L'orario di lavoro prevede il 70% in smart working, mentre il restante 30% sarà dedicato ad attività in sede e presso i clienti assegnati per il monitoraggio dei progetti. Per i candidati residenti a Verona o nelle zone limitrofe, è richiesta una presenza in ufficio pari al 50%Sedi di lavoro indicative:VERONA - PARMA- PADOVA - MILANO#J-18808-Ljbffr



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