Qualified Person

Novartis

Baarle Nassau, , NL
Quality assurance and compliance
Gmp-compliant system management
Batch release and analysis
Responsible for the timely release of radiopharmaceutical products to ensure a reliable supply chain in compliance with European Union pharmaceutical regulations and Dutch law

Job Summary

  • Responsible for the timely release of radiopharmaceutical products to ensure a reliable supply chain in compliance with European Union pharmaceutical regulations and Dutch law.
  • Serve as Subject Matter Expert during Health Authority inspections and audits, maintaining the Quality Manual and supporting quality culture through coaching and training on cGMP requirements.
  • Work in shifts or provide on-call support to supervise quality assurance and control activities and replace the Quality Operations Manager in case of absence.

Matching Summary

Responsible for the timely release of radiopharmaceutical products to ensure a reliable supply chain in compliance with European Union pharmaceutical regulations and Dutch law.

Skills & Requirements

Must-have

  • Quality assurance and compliance
  • GMP-compliant system management
  • Batch release and analysis
  • Regulatory requirements knowledge
  • Quality oversight of operational activities
  • Deviation and CAPA investigations

Nice-to-have

  • Collaboration and communication skills
  • Agile mindset and continuous improvement
  • Leadership and coaching abilities
  • Digital savviness
  • Problem solving skills
  • Organizational savviness
  • Smart risk taking

Key Requirements

  • Master Degree in scientific disciplines
  • 3+ years experience in pharmaceutical Quality Assurance
  • Fluent in English

Work Rights

Not specified

Tailored Resume

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