Review of quality investigations and non-conformances
Provides QA support to the introduction, launch, and lifecycle transition of new products to the Leiden manufacturing site
Job Summary
Provides QA support to the introduction, launch, and lifecycle transition of new products to the Leiden manufacturing site.
Assesses and reviews Quality Investigations and non-conformances, supports investigation teams, ensures robust root cause analysis, and determines product impact and disposition based on GMP and compliance considerations.
Acts as quality SME and supports preparation for, and participation during, inspections (e.g. FDA, EMA), including APR activities and inspection readiness, to ensure successful audits.
Matching Summary
Provides QA support to the introduction, launch, and lifecycle transition of new products to the Leiden manufacturing site.