QA On The Floor

6 mesi fa


Caponago, Italia S&You A tempo pieno

S&you, brand internazionale dedicato al Professional Staffing e Ricerca e Selezione di personale qualificato e middle management, seleziona per nota azienda farmaceutica un/una QUALITY ASSURANCE ON THE FLOOR

**Posizione**:
La risorsa si occuperà di svolgere sorveglianza delle attività produttive, nei reparti di produzione, diffondendo pro-attivamente la Quality Culture all’interno dei reparti.

**Principali responsabilità**:

- Supporta la direzione QA nell’implementazione, controllo e miglioramento continuo del Sistema di Gestione della Qualità aziendale, attuato secondo EU GMP.
- Effettua sorveglianze periodiche delle attività produttive e promuove la Quality Culture diffondendola pro-attivamente all’interno dei reparti.
- Collabora con la Quality Unit e con il reparto Produzione al fine di assicurare la corretta esecuzione delle indagini riscontrate sul campo, fornendo supporto per la comprensione delle cause e partecipando all’identificazione delle più idonee azioni correttive o preventive, in accordo agli standard qualitativi aziendali ed alle normative vigenti.
- Partecipa, in collaborazione con il reparto Produzione, al miglioramento continuo del Reparto, fornendo supporto nell’implementazione di nuovi flussi e nell’ottimizzazione di procedure.
- Partecipa alle verifiche ispettive interne per sincerarsi che tutte le attività dell’organizzazione avvengano in conformità a quanto descritto nella documentazione del Sistema di Gestione della Qualità: GMP, GDP, e GVP.
- All’interno della Quality Unit funge da backup/supporto alle altre figure nelle attività di: gestione dei Cambi (change management), all’interno dell’officina e per i Fornitori, secondo le procedure aziendali; gestione Deviazioni di prodotto/processo e gestione delle Azioni Correttive e Preventive (“CAPA”); revisione del Product Quality Review (“PQR”); revisione dei Batch Record e IFL dei prodotti fabbricati nell’officina.
- Collabora nella preparazione ed esecuzione delle ispezioni da parte di Autorità Regolatorie.
- Collabora nella realizzazione di specifici progetti in accordo ai piani aziendali.

**Requisiti**:

- Laurea in Farmacia, CTF, Chimica o facoltà affini
- Esperienza di almeno 3 anni nel ruolo
- Provenienza da contesti produttivi di sterili iniettabili
- Proattività e problem solving

**Altre informazioni**:
L'inquadramento e la retribuzione saranno commisurati all'esperienza della risorsa.- Le persone interessate sono invitate a leggere l'_informativa privacy_ ex artt. 13 e 14 del Reg. UE 2016/679._
- Aut. Min. Prot. N. 1207 - SG del 16/12/2004_


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