CSA & Quality Compliance Expert with at least 3 years of experience in Computer System Validation to support compliance and validation projects for our clients, including top pharmaceutical, biotech, and medical device companies.
Role Description:
The selected candidate will work as a consultant on client projects, managing and supporting the validation of computerized systems in regulated environments. They will contribute to strategic initiatives in Life Science and Medical Device compliance, ensuring systems align with regulatory requirements, GxP/ISO standards, and industry best practices. Knowledge of medical device compliance is considered a plus.
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 13485, 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
Requirements:
• Degree in scientific or technical disciplines (Engineering, Computer Science, Biotechnology, Chemistry, etc.).
• At least 3 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 GxP 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.
