Equipment Validation Specialist
3 settimane fa
Lo stabilimento produttivo di Monza è un centro di eccellenza globale per quanto riguarda le produzioni di farmaci sterili conto terzi. Entrerai a far parte di un team di oltre 1900 colleghi in un ambiente giovane, dinamico e fortemente orientato all'obiettivo. Con un fatturato di oltre 40 miliardi di dollari e i più grandi investimenti in R&D del settore, Thermo Fisher Scientific fornisce alle persone le risorse e le opportunità per contribuire in maniera significativa al raggiungimento del nostro obiettivo: aiutare i nostri clienti a rendere il mondo un luogo più sano, pulito e sicuro.
Nel ruolo di Equipment Validation Specialist supporterai il responsabile nell’attività di coordinamento del Team interno di specialisti, volta alla validatione di equipments e utilities per verificarne il buon funzionamento dei sistemi stessi, nel rispetto delle esigenze di produzione, delle norme GMP, degli standard di qualità e delle normative vigenti in materia di sicurezza.
In particolare, seguirai le seguenti attività:
- Supportare Equipment Validation Team nell’assicurare la convalida degli equipment aziendali relativi alla produzione di medicinali iniettabili sterili e alla pulizia degli equipment di produzione, attraverso la stesura di protocolli/report di convalida e documenti tecnici, nel rispetto delle normative vigenti (norme GMP, FDA, EMA etc.).
- Stesura protocolli/report di convalida.
- Stesura di protocolli/report di convalida relativi ai utilities e agli equipment che devono essere sottoposti a convalida, al fine di acquisire informazioni necessarie alla stesura dei protocolli, l’esecuzione delle attività di convalida e la stesura dei rapporti di convalida, nel rispetto delle procedure aziendali.
- Stesura documentazione tecnica.
- Partecipare ai team di progetto discutendo aspetti tecnici della strategia di convalida da sottomettere alle autorità regolatorie. Scrivere documentazione tecnica di Convalida, nel rispetto delle procedure aziendali.
- Supportare l’esecuzione delle attività operative dal punto di vista tecnico.
- Revisionare i dati generati dalle attività di convalida e la loro analisi, nel rispetto dei protocolli e delle procedure aziendali.
Requisiti e qualifiche
- Studi/Diploma/Corsi di formazione: Laurea in CTF, Farmacia, Chimica, Biotecnologie, Biologia, analoghe lauree a indirizzo scientifico o comprovata esperienza.
- Buona conoscenza dei principi di funzionamento di equpments farmaceutici.
- Buona conoscenza della lingua inglese.
- Buona conoscenza delle norme cGMP.
- Buona conoscenza dei sistemi informatici e degli applicativi MS Office.
- Elevata capacità di determinazione e problem solving.
- Capacità di operare in parallelo su diversi progetti.
- Propensione al lavoro di gruppo.
Consolidata esperienza lavorativa nel campo della convalida equipment.
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