Specialist Quality Assurance - Qa Npd

Johnson & Johnson

Leiden, Netherlands
Base: 53,500.00 to 85,445.00; bonus/equity: not sp...
Quality oversight for new product introduction
Gmp compliance throughout product lifecycle
Review and approve document changes
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; Bonus/Equity: Not specified; Benefits: 8% holiday allowance

Skills & Requirements

Must-have

  • Quality oversight for new product introduction
  • GMP compliance throughout product lifecycle
  • Review and approve document changes
  • Participate in risk assessments
  • Support site and global escalation meetings

Nice-to-have

  • Foster strong quality and compliance culture
  • Customer-oriented attitude
  • Negotiation skills
  • Empowered professional

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 of Global Regulatory guidelines

Work Rights

Not specified

Tailored Resume

Cover Letter