About the Role
Perform QA oversight on assigned external suppliers and third parties manufacturing products, ensuring that the delivered products comply with quality standards and legal requirements.
Monitor third party KPI’s to proactively detect and notify to QA management any compliance issue on supplier level that would risk supply of products.
Review and assess external customer complaints in the global complaint system, including Root Cause Investigation correctness, product impact assessment, trend/recurrence evaluation, and proposed CAPA assessment.
Review batch release documentation provided by third parties to support or act as Authorized Person for release of products for shipment including material status change in SAP.
Your Background:
Scientific Degree or an equivalent in Chemistry, Biology, Pharmacy or Pharmaceutical Engineering.
Experience in quality operations in the GMP environment.
Knowledge and understanding of regulatory requirements.
Good knowledge in office tools (e.g. Word, Excel, SAP).
Experience of QA systems.