Equipment Validation Specialist

3 settimane fa


Lombardia, Italia Buscojobs A tempo pieno

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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