Csa & Quality Compliance Expert
Pubblicato il 27-08-2026 - Ntt Data Europe & Latam in Bardi
Perché NTT DATA?
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CSA & Quality Compliance Expert
3-5 anni di esperienza in Computer System Validation per supportare progetti di conformità e validazione per clienti, inclusi top pharmaceutical, biotech e medical device companies.
Role Description
Il candidato selezionato lavorerà come consulente su progetti client, gestendo e supportando la validazione di sistemi informativi in ambienti regolamentati.
Contributo a iniziative strategiche per Life Science e Medical Device compliance, assicurando l'allineamento con requisiti regolatori, standard Gx P/ISO e best practice del settore.
La conoscenza della compliance dei dispositivi medici è considerata un vantaggio.
Key Responsibilities Draft and review validation documentation in compliance with industry regulations.
Participate in validation projects for computerized systems, including ERP, MES, LIMS, SCADA and Data Integrity solutions.
Support compliance projects in the Medical Device sector, ensuring adherence to ISO *****, EU MDR and other relevant regulations.
Perform risk assessments and impact analyses for computerized systems in both pharma/biotech and medical device environments.
Collaborate with cross-functional teams, including IT, QA and operations, to ensure compliance with standards and regulations.
Provide support during client and regulatory audits (FDA, EMA, ISO etc.), supplying evidence and required documentation.
Deliver training and guidance to client personnel on validation and compliance activities for Life Science and Medical Device sectors.
Requirements Degree in scientific or technical disciplines (Engineering, Computer Science, Biotechnology, Chemistry etc.).
At least 3-5 years of experience in CSA activities within Life Science.
Solid understanding of regulatory guidelines: GAMP 5, FDA 21 CFR Part 11, EU Annex 11.
Experience with risk-based validation approaches and familiarity with software validation in Gx P contexts.
Ability to manage complex projects and effectively collaborate with clients across multiple industries.
Excellent analytical, planning and problem-solving skills.
Proficiency in English, both written and spoken.
Sede di lavoro
Milano, con possibilità di modalità di lavoro Ibrida (Smart Working).
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