Qualified Person

Johnson & Johnson

Sassenheim, Netherlands
Base: 88.400 eur - 119.600 eur; holiday allowance:...
Quality oversight of at products
Gmp compliance
Root cause investigations
Provides Quality oversight to the production of Commercial and/or clinical AT Products (Lentiviral) at the site

Job Summary

  • Provides Quality oversight to the production of Commercial and/or clinical AT Products (Lentiviral) at the site.
  • Assesses non-conformances for possible impact on product quality or compliance status and decide on product disposition.
  • Releases Drug Substance lots manufactured (for global distribution), ensuring safety, efficacy and quality of product released by JBV.

Matching Summary

Provides Quality oversight to the production of Commercial and/or clinical AT Products (Lentiviral) at the site.

Salary

Base: 88.400 EUR - 119.600 EUR; Holiday Allowance: 8%; Benefits: Not specified

Skills & Requirements

Must-have

  • Quality oversight of AT products
  • GMP compliance
  • Root Cause investigations
  • Corrective and Preventative actions
  • Risk assessments
  • Global Regulatory guidelines (cGMP/ICH/FDA/EMA)

Nice-to-have

  • Process Excellence
  • Co Think
  • Kepner-Tregoe
  • Inclusive Leadership
  • Fact-Based Decision Making
  • Empowered professional

Key Requirements

  • Bachelor’s degree or higher in Biochemistry, Biology, Pharmaceutical degree or relevant education
  • Proven knowledge of the biotechnological/lentiviral/pharmaceutical industry
  • Proficiency in English
  • Broad knowledge of QA systems

Work Rights

Not specified

Tailored Resume

Cover Letter