COMPUTER SYSTEM VALIDATION

1 settimana fa

Verona, Provincia di Verona, Italia Orienta A tempo pieno

Orienta Spa, Societ Benefit filiale di Verona, ricerca per realt di consulenza COMPUTER SYSTEM VALIDATION &, DATA INTEGRITY CONSULTANT – GxP La figura lavorer su progetti di validazione e compliance che coinvolgono processi GxP (GMP, GCP, GLP, GVP), supportando aziende farmaceutiche, CRO, dispositivi medici e strutture sanitarie. Attivit previste: - Analisi dei requisiti regolatori GxP per sistemi computerizzati e piattaforme digitali - Redazione 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/procedurali - Supporto a Audit GxP interni ed esterni - Gestione di change control, deviazioni, incident e CAPA su applicativi e infrastrutture IT - Training agli utenti finali sulle procedure di compliance e DI Requisiti - Laurea in discipline scientifiche o ingegneristiche - Esperienza nel ruolo CSV in contesti multi-GxP - Conoscenza delle linee guida internazionali (GAMP 5, FDA, EMA, WHO Data Integrity) - Familiarit con architetture IT, applicativi enterprise e sistemi di laboratorio - Buona padronanza della lingua inglese Soft Skills - Adattabilit a contesti diversi (QC, QA, Clinical, Engineering, IT) - Capacit organizzativa e gestione di più progetti - Proattivit , precisione e orientamento alla qualit - Comunicazione efficace e capacit di relazione con il cliente Si propone: - Inserimento diretto in azienda - CCNL applicato: Chimica Industria * 13 mensilit - Orario di lavoro: Full-time 40 ore dal lunedì al venerdì. L'orario di lavoro prevede il 70% in smart working, mentre il restante 30% sar dedicato ad attivit 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 Settore: Ingegneria Ruolo: IT/Technology Tipo di occupazione: Contratto a tempo determinato vetrinabakeca

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