Jr Computer System Validation
2 mesi fa
Ricerchiamo una figura di Junior Computer System Validation che lavorerà a stretto contatto con il team europeo per garantire la conformità GMP richiesta per tutti i sistemi computerizzati in uso presso l'azienda.
Principali mansioni:
- Supportare le attività di convalida;
- Collaborare alla valutazione delle modifiche ai sistemi computerizzati dal punto di vista dei requisiti normativi e di integrità dei dati;
- Collaborare all'indagine e alla risoluzione dei problemi di conformità (Deviazione e CAPA).
- Verificare se un sistema computerizzato è progettato secondo i requisiti normativi e di integrità dei dati applicabili: revisione dei requisiti utente e delle specifiche software;
- Collaborare alla consegna dei documenti di convalida dei sistemi computerizzati;
-Collaborare per garantire che il sistema sia mantenuto nello stato di convalida con conforme documentazione e gestire il processo di "revisione periodica" dei sistemi computerizzati pertinenti.
- Mantenere aggiornato l'"Inventory List" dei sistemi computerizzati EUBPT; Collabora con il team di audit interno/fornitore durante l'audit nell'area GAMP.
- Esperienza pregressa di 6 mesi/1 anno nel ruolo di convalida dei sistemi informatici preferibilmente nel settore farmaceutico o delle scienze biologiche.
- Conoscenza della normativa GMP per i sistemi informatici (EU GMP-volume 4 allegato 11; CFR21 parte 11) è preferibile;
- a conoscenza dei principi CFR Parte 11 e EU GMP Allegato 11 è considerata un plus;
- Conoscenza delle linee guida GAMP;
- Ottima capacità di parlare e scrivere in inglese, anche di documentazione tecnica
- Disponibilità a trasferte frequenti su territorio europeo
Ottima opportunità di crescita professionale in un contesto internazionale e dinamico.
Modalità di lavoro Ibridap
Jr Computer System Validation
Location: Milano Est
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