CSA & Quality Compliance Expert
Pubblicato il 14-09-2026 - Ntt Data in Monza
Overview
In this role you will support compliance and validation projects for regulated environments in life science and medical device sectors. You will work as a consultant on client projects, steering the validation of computerized systems and contributing to strategic compliance initiatives. The position involves collaborating with IT, QA, and operations to ensure systems meet GxP/ISO standards and regulatory expectations. You will help prepare documentation, support audits, and deliver training, enabling clients to maintain compliant, validated systems. This opportunity offers hands-on impact across pharma, biotech, and medical device contexts, with room to shape validation practices and risk‑dr
Retribuzione / Benefits
- aggiornamento continuo
- programmi di apprendimento avanzati
- piani di crescita personalizzati
- Smart Working/ibrido
- ambiente di lavoro internazionale
- percorso di sviluppo professionale
Responsabilità
- Draft and review validation documentation in compliance with industry regulations
- Participate in validation projects for computerized systems (ERP, MES, LIMS, SCADA)
- Support compliance projects in Medical Device sector (ISO 13485, EU MDR)
- Perform risk assessments and impact analyses for computerized systems
- Collaborate with IT, QA, and operations to ensure compliance
- Assist during client and regulatory audits (FDA, EMA, ISO) with evidence and documentation
- Deliver training and guidance on validation and compliance for Life Science and Medical Device sectors
Requisiti fondamentali
- 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 GAMP 5, FDA 21 CFR Part 11, EU Annex 11
- Experience with risk-based validation approaches and software validation in GxP contexts
- Ability to manage complex projects and collaborate with clients across industries
- Excellent analytical, planning, and problem-solving skills
- Proficiency in English, both written and spoken
- analytical thinking
- planning
- problem-solving
- GAMP 5
- FDA 21 CFR Part 11
- EU Annex 11