- 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
- 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
- Esperienza nel settore farmaceutico
- Conoscenza delle normative di riferimento (US, EU) e degli standard di convalida ( e.g. GAMP)
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Computer System Validation - Carlentini Nord, Italia - Orienta
Descrizione
Orienta Spa Società Benefit - filiale di Verona, ricerca per azienda cliente specializzata sui servizi di Data Integrity, Computerized System Validation e IT Governance & Compliance un/a Computer System Validation & Data Integrity Consultant - Parma
Il candidato si occuperà di:
Il profilo ricercato è in possesso di:
Requisiti preferenziali:
orario di lavoro full time dal lunedì al venerdì. Previsto alloggio e trasferte retribuite per tutta la durata del progetto (circa 6 mesi) al termine del quale il lavoro verrà svolto un 70% in smart working e un 40% presso clienti (rimborso spese ad ogni trasferta). Iniziale contratto a T. determinato scopo assunzione.
Settore: Informatica
Ruolo: IT/Technology
Tipo di occupazione: Lavoro a tempo indeterminato