- Stesura Validation Plan e Validation Report
- Conduzione di Data Integrity Assessment di attività di remediation
- Esecuzione di GxP Risk Assessment sui sistemi computerizzati
- Emissione, compilazione e revisione di documentazione convalida software
- Emissione e revisione dei protocolli di test di qualifica (IQ, OQ e PQ)
- Gestione dei processi di Change Control e Periodic Review Il profilo ricercato è in possesso di:
- Laurea in discipline scientifiche: Ingegneria ( Informatica, Biomedica, Meccanica o Gestionale) / Biotecnologie / Chimica / CTF anche neolaureato
- Ottima conoscenza del Pacchetto Office
- Conoscenza della lingua inglese
- Propensione alle relazioni interpersonali Requisiti preferenziali:
- Pregressa esperienza nel settore farmaceutico
- Conoscenza delle normative di riferimento (US, EU) e degli standard di convalida ( e.g. GAMP) orario di lavoro full time dal lunedì al venerdì
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Computer System Validation - Italia - Orienta Filiale di Verona
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Descrizione
Orienta Spa Agenzia per il lavoro filiale di Verona, ricerca per azienda cliente specializzata sui servizi di Data Integrity, Computerized System Validation e IT Governance & Compliance un* Computer System Validation & Data Integrity Consultant - Italia
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