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MANUFACTURING PROCESS COMPLIANCE ENGINEER
Bologna e provincia
EUR35,000 - EUR45,000Updated 09/11/16
- Ottima opportunità di carriera
- Ottima conoscenza GMP
Il nostro cliente
Il nostro cliente è una nota multinazionale del settore chimico
La figura ricercata
- Actively participate to maintain accurately all Process Characterization documentation and databases.
- Revise and create processes, procedures, forms, etc. as necessary to maintain compliance and effectiveness of Quality Management System.
- Assist Manufacturing in maintaining daily compliance to FDA and regulatory affairs.
- Review validation/verification protocols to support new product/process development and changes to existing products/processes.
- Partners with Manufacturing, QA Production Support and Validation team to ensure compliance of products in an ever-changing regulatory environment.
Collaborate with process and manufacturing engineers by actively participating in risk analysis, ensuring standardization between process steps.
He/She is able to prepare/revise SOP's, change control documentation, investigations, CAPA's and training materials used by the Manufacturing team in the performance of their work.
- Have a strong commitment to quality assurance, and a willingness to support the quality first culture on the Site.
- Writes and support Manufacturing team on change controls. Proposes and drafts changes to SOPs.
Il candidato prescelto
- minimo 3 anni di esperienza in un ruolo analogo
- Laurea in Chimica,chimica industriale,Ingegneria chimica,CTF
- inglese: fluente
Cosa comprende l'offerta
Ottima opportunità di carriera.