Base: 53,500.00 to 85,445.00 annually; bonus/equit...
Gmp compliance
New product introduction
Quality investigations
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.
Salary
Base: 53,500.00 to 85,445.00 annually; Bonus/Equity: Not specified; Benefits: 8% holiday allowance
Skills & Requirements
Must-have
GMP compliance
New Product Introduction
Quality Investigations
CAPA development
Risk assessments
GMP training
Change control review
Nice-to-have
Process Excellence methods
Co Think methods
Kepner-Tregoe methods
Customer-oriented attitude
Influences without formal authority
Key Requirements
Bachelor's degree or higher in Biochemistry, Biology, Pharmaceutical degree or relevant education
BSc 6 years or MSc 4 years of experience in a GMP regulated environment
Proficiency in English both in word and in writing
Deep understanding and application of Global Regulatory (cGMp/ICH/FDA/EMA) guidelines