CSA & Quality Compliance Expert

Experteer 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

• 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

Responsabilità

• 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

Requisiti fondamentali

• formazione continua
• programmi di apprendimento avanzati
• piani di crescita personalizzati
• Smart Working/ibrido
• ambiente di lavoro internazionale
• percorso di sviluppo professionale