OverviewIn 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 / Benefitsformazione continua
programmi di apprendimento avanzati
piani di crescita personalizzati
Lavoro da remoto/ibrido
ambiente di lavoro internazionale
percorso di sviluppo professionale
ResponsabilitàDraft 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 *****, 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 fondamentaliDegree 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

📌 Csa & Quality Compliance Expert (Bardi)
🏢 Ntt Data
📍 Bardi