Quality Supervisor

3 mesi fa


Ferentino, Italia Thermo Fisher Scientific A tempo pieno

**Work Schedule**

Standard (Mon-Fri)

**Environmental Conditions**

Office

Thermo fisher Scientific, World leader in serving Science, sta cercando un Quality Supervisor per il sito di Ferentino (FR). La risorsa si occuperà delle seguenti attività:
**Audit ed Ispezioni**
- Supportare il Quality Department nella preparazione e nella partecipazione attiva agli audit da parte dei clienti e alle ispezioni degli enti regolatori, fornendo informazioni e documentazione necessarie.

**Deviations/CAPA/Change**
- Supportare il Quality Department nelle investigazioni associate a deviazioni in cui sia necessario un supporto tecnico.
- Assicurare che il TCS Department rispetti i tempi assegnati per la chiusura di CAPA e action item.
- Valutare i Change di sito per l’intero TCS Department.

**SOP**
- Assicurare che le SOP del gruppo TCS siano in linea agli standard di qualità aziendali e sito.
- Revisionare e/o Approvare le SOP del gruppo TCS e la documentazione di competenza.
- Assicurare la corretta archiviazione della documentazione prodotta del gruppo di manutenzione (logbook).

**Data Integrity**
- Assicurare che tutte le attività del gruppo TCS avvengano in linea coi principi ALCOA+ e Data Integrity.

**Analisi dei dati e della documentazione técnica**
- Revisionare/Approvare l’analisi e la valutazione dei dati e dei risultati delle attività di qualifica e/o di manutenzione/calibrazione.
- Assicurare l’emissione dei piani delle attività di Manutenzione, Calibrazione e Riqualifiche on time ed approvarne i contenuti.

**Gestione del personale dipendente**
- Assicurare l’indirizzo, il coordinamento e il controllo della struttura dipendente, attraverso la definizione degli obiettivi, la valorizzazione dei risultati, l’analisi dei bisogni formativi e di sviluppo, al fine di garantire un alto livello di performance e motivazione.

**Budget**
- Supportare il Superiore nella predisposizione e proposta del budget della funzione, attraverso la fornitura dei dati necessari e la proposta dei budget dell’area di competenza, nel rispetto degli standard aziendali.

Requisiti:

- Laurea in Ingegneria, CTF, Scienze Biologiche o simili.
- Comprovata pregressa esperienza nella gestione di audit in ambito farmaceutico.
- Ottima conoscenza delle normative di riferimento EU & US.
- Ottima conoscenza della lingua Inglese, sia scritta che parlata.


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