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Quality Assurance

4 mesi fa

Milano, Italia Manpower A tempo pieno
Manpower professional, divisione Life Sciences, per cliente del settore Api, sta ricercando un profilo di:

QUALITY ASSURANCE SPECIALIST

Il QA risponde al Quality Unit Manager ed al QA Supervisor 
Il profilo si occuperà di:
- Rivedere ed approvare i batch record di produzione e bollettini analitici prima della revisione da parte del Qualified Person
- Revisionare i Fogli di spedizione e approvazione DTT
-Revisionare i Master Batch record e confrontare quanto riportato nel DMF rispetto a quanto riportato nel MBR. DOve necessario revisionare la documentazione in collaborazione con il reparto R&D
- redigere i seguenti documenti:
  • deviazione, change control, fuori specifica reclami e resi. Collaborare insieme ai responsabili di reparto nell'investigazione delle pratiche di non conformità e propone azioni correttive e preventive
  • Il Product Quality Review e proporre azioni correttive e preventive
  • I protocolli e i report di convalida di processo e di cleaning e proporre azioni correttive e preventive 
  • Le procedure ed ove richiesto esecuzione dei training
  • Verificare lo stato di avanzamento delle Corretive and Preventive Actions
  • Partecipare attivamente nell'Applicazione del Quality Risk management per gli Aspetti di propria competenza
  • gestire il piano di controllo di cleaning annuale da effettuare sulle attrezzature di produzione ed organizzare i monitoraggi periodici
  • Utilizzare il sistema ERP SIAS
Profilo:
- laurea Scientifica
- anni di esperienza nel ruolo

contratto diretto con il cliente
sede: nei pressi di Vimodrone (NORD di MILANO)