Computer System Validation Specialist

3 settimane fa

Faenza, Italia Tema Sinergie spa A tempo pieno

Tema Sinergie, consolidata realtà in fase di forte espansione sul territorio nazionale e sui mercati esteri, specializzata nella progettazione, produzione e commercializzazione di soluzioni tecnologiche rivolte al settore farmaceutico ed ospedaliero.

**Computer System Validation Specialist (CSV)**:
Siamo alla ricerca di una figura di Progettista CSV in un'ottica di sviluppo dell'organizzazione aziendale.
La risorsa verrà inserita all'interno di un team strutturato riportando direttamente al Coordinatore CSV.

**Nello specifico, la risorsa si occuperà di**:
Preparazione, redazione e cura della documentazione técnica Redazione Specifiche Tecniche, Funzionali e di Design
Redazione protocolli di test interni
Redazione e successive revisioni dei Protocolli di validazione, “in-factory” e “on-site” (FAT, SAT, IQ-OQ) nel rispetto della pianificazione assegnata, delle necessità del cliente (col quale avrà un canale diretto), degli standard qualitativi e delle normative applicabili Documentazione di analisi rischi
Supporto al post-vendita per redazione documenti di change control e valutazione impatto modifiche
Gestione diretta, o tramite supporti esterni, della traduzione della documentazione nelle lingue richieste dal Cliente
Supporto alla redazione dei manuali d’uso e manutenzione
Supporto, esecuzione e, gestione della documentazione di validazione in-factory e presso i clienti

Requisiti
Esperienza anche mínima nel ruolo di Computer System Validation Specialist in aziende operanti in ambito progettazione macchine per i settori biomedicale, farmaceutico o food and beverage;
Laurea Triennale o Magistrale in ambito Ingegneristico o Scientifico;
Buona conoscenza della lingua Inglese (B2/C1), gradita una seconda lingua;
Disponibilità a saltuarie trasferte presso clienti in sede di SAT;
Ricerchiamo una risorsa dotata di buone capacità organizzative e di relazione, in grado di potersi interfacciare con più livelli gerarchici e con i clienti finali. Per il ruolo sono importanti caratteristiche quali precisione, proattività e determinazione. Completano il profilo propensione all’apprendimento, curiosità e senso critico.

Si offre
Iniziale contratto tempo determinato scopo assunzione

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