Process And Cleaning Validation Specialist

1 mese fa

Monza, Italia Thermo Fisher Scientific A tempo pieno

Thermo Fisher Scientific, World Leader nel servire la Scienza, sta cercando per il suo Gruppo di Qualità nel sito di Monza un Process and Cleaning Validation Specialist.
**SCOPO DELLA POSIZIONE/RESPONSABILITÀ**:
Supportare il Process & Cleaning Validation Team Leader nell'assicurare la convalida dei processi aziendali relativi alla produzione di medicinali iniettabili sterili e alla pulizia degli equipment di produzione, attraverso la revisione di protocolli, report e documenti tecnici, nel rispetto delle normative vigenti (norme GMP, FDA, EMA etc.), delle indicazioni contenute nel dossier e degli standard di qualità aziendali.
Supportare nello svolgimento delle ispezioni regolatorie.
**COMPITI SPECIFICI/ATTIVITÀ PRIMARIE**:
Analisi della documentazione técnica
- Valutare la documentazione técnica relativa ai processi di fabbricazione o alle procedure di pulizia che devono essere sottoposti a convalida, al fine di acquisire informazioni necessarie alla revisione dei protocolli, l'esecuzione delle attività di convalida e la stesura dei rapporti di convalida, nel rispetto delle procedure aziendali.
Revisione protocolli
- Partecipare ai team di progetto discutendo aspetti qualitativi della strategia di convalida da sottomettere alle autorità regolatorie. Revisionare i Protocolli di Convalida, nel rispetto delle procedure aziendali.
Convalida
- Supportare l'esecuzione delle attività operative dal punto di vista qualitativo.
Rapporti di convalida
- Revisionare i dati generati dalle attività di convalida e la loro analisi, nel rispetto dei protocolli e delle procedure aziendali.
Change Control
- Revisionare i change control relativi alle attività di convalida.
REQUISITI E QUALIFICHE: ESSENZIALI
- Studi/Diploma/Corsi di formazione: Laurea in CTF, Farmacia, Chimica, Biotecnologie, Biologia, analoghe lauree a indirizzo scientifico o comprovata esperienza
- Conoscenze tecniche e informatiche: Produzione e controllo della produzione di prodotti farmaceutici, Norme GMP/FDA
- Lingue: Inglese e Italiano
- Ottime doti relazionali, proattività, capacità di lavorare in team
DESIDERABILI: Conoscenza dei principali sistemi informatici aziendali (PMX, LIMS, Trackwise, Minitab) e degli strumenti Microsoft Office; conoscenza di base della convalida di processo/pulizia.

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