Equipment Validation Specialist

3 settimane fa


Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
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.
Il tutto sempre nel rispetto delle esigenze di produzione, delle norme GMP, degli standard di qualità e delle normative vigenti in materia di sicurezza.
Entrerai in un contesto dinamico, internazionale e dotato di tecnologie allo stato dell'arte.
Grazie alla collaborazione con tutte le funzioni aziendali, e facendo leva sulle tue competenze nel campo dei sistemi di ispezione visiva automatica, contribuirai ad assicurare la soddisfazione delle aziende farmaceutiche nostre clienti.
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.
**Compiti specifici/attività primarie**
- Stesura protocolli/report di convalida
- Stesura di protocolli/report di convalida relativi ai alle 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 técnica
- Partecipare ai team di progetto discutendo aspetti tecnici della strategia di convalida da sottomettere alle autorità regolatorie.
Scrivere documentazione técnica di Convalida, nel rispetto delle procedure aziendali.
- Convalida
- Supportare l'esecuzione delle attività operative dal punto di vista tecnico.
- Rapporti di convalida
- 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
**Desiderata**
Consolidata esperienza lavorativa nel campo della convalida equipment.


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