CSV Specialist
2 settimane fa
Adecco LifeScience, divisione specializzata del Gruppo Adecco, ricerca per azienda cliente in ambito farmaceutico con sede in provincia Monza Brianza un/a
Computerized systems & compliance specialist
la risorsa si occuperà di:
- verifica che un sistema computerizzato sia stato progettato in accordo alle vigenti normative: redige e/o revisiona documenti come URS e FDS;
- è responsabile della gestione della documentazione di convalida e del coordinamento delle attività legate alla stessa;
- valuta ed approva le modifiche al sistema dal punto di vista normativo e di integrità dei dati;
- assicura che il sistema computerizzato sia mantenuto "in convalida" durante il suo intero ciclo di vita e che la relativa documentazione rimanga aggiornata.
- Gestisce il processo di "periodic review" dei sistemi computerizzati; mantiene aggiornato l'elenco locale dei sistemi computerizzati convalidati "inventory list";
- è coinvolto nelle investigazioni e nella risoluzione di deviazioni che possono sorgere;
- coordina e supervisiona eventuali attività delegate a consulenti esterni qualificati mantenendo la responsabilità a suo carico
- può essere coinvolto negli audit interni/esterni dell'area GAMP;
Per i Sistemi di Laboratorio (LAS) locali:
- Collabora, con la funzione "Documentation & QC Compliance" al fine di verificare che un sistema computerizzato sia stato progettato in accordo alle vigenti normative: revisiona documenti come URS e FDS;
- prepara la documentazione di convalida ed eseguire le attività ad essa associate;
- valuta le modifiche al sistema dal punto di vista normativo e di integrità dei dati;
- assicura che il sistema computerizzato sia mantenuto "in convalida" durante il suo intero ciclo di vita e che la relativa documentazione rimanga aggiornata.
- Gestisce il processo di "periodic review" dei sistemi computerizzati; mantenere aggiornato l'elenco locale dei sistemi computerizzati convalidati "inventory list";
- è coinvolto nella gestione delle investigazioni e nella risoluzione di deviazioni che possono sorgere.
Il profilo ideale possiede:
- Minimo 2-3 anni di esperienza in ambito farmaceutico/chimico nel reparto QA in ambito afferente alla Computer system Validation Education
- Laurea in materia scientifica (Ingegnere Informatico/Ingegnere Chimico/Chimica/CTF) con back ground anche in ambito di Chimica Organica
- Buona Conoscenza della lingua inglese Professional knowledge
- Buona Conoscenza delle GxP
- Buona conoscenza dei sistemi informatici
- Buona conoscenza degli items del Quality Assurance Skills
- Capacità di comunicazione e capacità di interazione con molteplici persone/reparti differenti
- Capacità di lavorare in squadra
- Orientamento ai risultati ed attitudine a risolvere i problemi
- Iniziativa e adattabilità
Si Offre contratto diretto in azienda, CCNL Chimico-farmaceutico, smart working e flessibilità
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