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PROCESS COMPLIANCE ENGINEER
Bologna e provincia
EUR35,000 - EUR45,000
Fluency in English
Il nostro cliente
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
Skills and competencies
- Honors / Masters degree in Biological sciences, Physical sciences, Engineering or equivalent skills through demonstrated experience.
- 2-5 yearsexperience in qualityassurance in tobacco, food, pharmaceutical or similarindustry
- Process/Quality experience in GMP (preferrable FDA) regulated Industry (Medical Device,Pharmaceutical,...).
- Project Management Skills- Internal Consulting Skills
- Fluency in English
Cosa comprende l'offerta
Ottima opportunità di carriera.