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The CSA & Quality Compliance Expert will support compliance and validation projects for leading pharmaceutical and medical device companies. With 3-5 years of experience in Computer System Validation, the candidate will draft validation documentation, participate in validation projects, and collaborate with cross-functional teams to ensure compliance with regulatory standards. A degree in a scientific or technical discipline is required, along with strong analytical and problem-solving skills. Proficiency in English is essential.
Job Responsibility:
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 and Medical Device sectors
Requirements:
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 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
Nice to have:
Knowledge of medical device compliance is considered a plus