ppCSA Quality Compliance Expert with 3-5 years of experience in Computer System Validation to support compliance and validation projects for our clients, including top pharmaceutical, biotech, and medical device companies.
/p h3Role Description /h3 pThe selected candidate will work as a consultant on client projects, managing and supporting the validation of computerized systems in regulated environments.
They will contribute to strategic initiatives in Life Science and Medical Device compliance, ensuring systems align with regulatory requirements, GxP/ISO standards, and industry best practices.
Knowledge of medical device compliance is considered a plus.
/p h3Key Responsibilities /h3 ul liDraft and review validation documentation in compliance with industry regulations.
/li liParticipate in validation projects for computerized systems, including ERP, MES, LIMS, SCADA, and Data Integrity solutions.
/li liSupport compliance projects in the Medical Device sector, ensuring adherence to ISO *****, EU MDR, and other relevant regulations.
/li liPerform risk assessments and impact analyses for computerized systems in both pharma/biotech and medical device environments.
/li liCollaborate with cross-functional teams, including IT, QA, and operations, to ensure compliance with standards and regulations.
/li liProvide support during client and regulatory audits (FDA, EMA, ISO, etc.), supplying evidence and required documentation.




/li liDeliver training and guidance to client personnel on validation and compliance activities for Life Science and Medical Device sectors.
/li /ul h3Requirements /h3 ul liDegree in scientific or technical disciplines (Engineering, Computer Science, Biotechnology, Chemistry, etc.).
/li liAt least 3-5 years of experience in CSA activities within Life Science.
/li liSolid understanding of regulatory guidelines: GAMP 5, FDA 21 CFR Part 11, EU Annex 11.
/li liExperience with risk-based validation approaches and familiarity with software validation in GxP contexts.
/li liAbility to manage complex projects and effectively collaborate with clients across multiple industries.
/li liExcellent analytical, planning, and problem-solving skills.
/li liProficiency in English, both written and spoken.
/li /ul h3Sede di lavoro /h3 pMilano, con possibilità di bmodalità di lavoro Ibrida (Lavoro da remoto) /b.
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📌 Csa & Quality Compliance Expert (Milano)
🏢 NTT America
📍 Milano