Quality Assurance Engineer
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Our client, a global pharmaceutical organization, is seeking a professional to oversee the quality management of third-party computerized systems providers. The role ensures that all external partners meet rigorous regulatory standards and internal compliance requirements through assessments and continuous performance monitoring.
- Perform qualification assessments of third-party computerized systems providers to verify suitability and competence.
- Conduct risk-based evaluations of external partners to determine appropriate quality control and oversight levels.
- Develop and maintain quality agreements and contractual quality clauses with third-party suppliers.
- Manage and update the qualified third-party database to ensure accurate referential data.
- Monitor routine quality performance of qualified partners and lead continuous improvement initiatives.
- Ensure comprehensive documentation and record-keeping of all third-party quality activities.
- Bachelor or Master in Life Sciences, Engineering, Computer Sciences, or a related field.
- You have 2+ years of experience in a GxP-regulated environment with a focus on third-party quality management.
- You bring knowledge of relevant regulations and guidelines such as FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.
- You possess strong analytical and risk assessment skills.
- You are fluent in Dutch and English.
Nice to Haves
- Knowledge of Computerized Systems Validation (CSV).