Quality Assurance Engineer

Il y a 2 jours

Geel, Antwerpen, Belgique Pauwels Consulting Temps plein 60 000 € - 85 000 €/an

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).