Computer System Validation

2 settimane fa

Lombardia, Italia agap2 Italia A tempo pieno

Computer System Validation (CSV) Specialist – Sede: Milano Tipo di Impiego : Full Time La risorsa sarà inserita nel team Quality/Compliance e si occuperà delle attività di convalida e qualificazione dei sistemi informatici utilizzati in ambito GxP (farmaceutico, medical device o biotech). Supporterà i progetti IT e Quality garantendo la conformità alle normative vigenti (GAMP 5, FDA 21 CFR Part 11, EU Annex 11). Responsabilità principali Sviluppo e aggiornamento della documentazione CSV: URS, RA, Validation Plan, IQ/OQ/PQ, Traceability Matrix, Validation Report. Esecuzione e revisione di test di convalida su sistemi software, strumenti di laboratorio, LIMS, ERP o MES. Gestione del ciclo di vita dei sistemi informatici secondo principi GAMP 5. Collaborazione con team cross-funzionali (IT, QA, Produzione, Laboratorio). Conduzione di valutazioni dei rischi (Risk Assessment) e definizione delle strategie di convalida. Gestione delle deviazioni, change control e CAPA legati ai sistemi informatici. Supporto in audit interni ed esterni (AIFA, FDA, clienti). Monitoraggio della compliance e aggiornamento alle normative di settore. Laurea in discipline scientifiche (Ingegneria, Chimica, Biotecnologie, Informatica o affini). Esperienza di almeno 1–3 anni in attività di Computer System Validation, preferibilmente in ambito Life Sciences. Conoscenza approfondita di GAMP 5, 21 CFR Part 11, Annex 11 e linee guida GxP. Buona capacità di redazione documentale in inglese e italiano. Approccio analitico, precisione e buone capacità di problem-solving. Capacità di lavorare in team e di gestire più progetti contemporaneamente. Se pensi possa essere l'opportunità giusta per te, non esitare a candidarti e ad inoltrarci il tuo CV #J-18808-Ljbffr

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