CSA & Quality Compliance Expert

Experteer Overview

In this role you will support compliance and validation projects for regulated Life Science environments, focusing on computerized systems across pharma, biotech, and medical devices. You will collaborate with IT, QA, and operations to ensure systems meet GxP/ISO standards and regulatory expectations. You’ll contribute to strategic initiatives in Life Science compliance and participate in client audits, risk assessments, and training. This position offers exposure to diverse industries and impactful work in regulatory quality.

Retribuzione / Benefits

• Draft and review validation documentation in line with regulations
• Participate in validation projects for ERP, MES, LIMS, SCADA, and Data Integrity solutions
• Support Medical Device compliance with ISO 13485, EU MDR, and related regs
• Perform risk assessments and impact analyses for computerized systems
• Collaborate with IT, QA, and operations to ensure standards
• Support client and regulatory audits (FDA, EMA, ISO) with evidence and documentation
• Deliver training on validation and compliance for Life Science and Medical Device sectors

Responsabilità

• Degree in scientific or technical disciplines (Engineering, Computer Science, Biotechnology, Chemistry, etc.)
• 3-5 years of CSA activities in Life Science
• Strong understanding of GAMP 5, FDA 21 CFR Part 11, EU Annex 11
• Experience with risk-based validation and software validation in GxP contexts
• Ability to manage complex projects and collaborate with clients across multiple industries
• Excellent analytical, planning, and problem-solving skills
• Proficiency in English (written and spoken)