About the role
CSA & Quality Compliance Expert Location Milan, Italy Category Other Add to cart Apply now Share via email Share via Facebook Share via LinkedIn Share via twitter
Key responsibilities
- check_circleCollaborate with the team on day-to-day project tasks
- check_circleLearn tools and processes used by the organization
- check_circleDocument work and participate in team meetings
- check_circleSupport quality checks and continuous improvement
Requirements
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- check_circleDraft and review validation documentation in compliance with industry regulations.
- check_circleParticipate in validation projects for computerized systems, including ERP, MES, LIMS, SCADA, and Data Integrity solutions.
- check_circleSupport compliance projects in the Medical Device sector, ensuring adherence to ISO 13485, EU MDR, and other relevant regulations.
- check_circlePerform risk assessments and impact analyses for computerized systems in both pharma/biotech and medical device environments.
- check_circleCollaborate with cross-functional teams, including IT, QA, and operations, to ensure compliance with standards and regulations.
- check_circleProvide support during client and regulatory audits (FDA, EMA, ISO, etc.), supplying evidence and required documentation.
- check_circleDeliver training and guidance to client personnel on validation and compliance activities for Life Science and Medical Device sectors.
- check_circleDegree in scientific or technical disciplines (Engineering, Computer Science, Biotechnology, Chemistry, etc.).
Skills & keywords
compliancecsaexpertltdnttquality
Benefits & perks
- check_circleMentorship
- check_circleCertificate of completion
- check_circleFlexible work arrangement where applicable