Qualified Person

Novartis UK

Baarle Nassau, Netherlands
Quality oversight for operational activities
Ensure compliance with dutch law
Gmp-compliant system implementation
Responsible for ensuring the quality of products and compliance with regulatory requirements and cGMP, including the timely release of radiopharmaceutical products for a reliable supply chain

Job Summary

  • Responsible for ensuring the quality of products and compliance with regulatory requirements and cGMP, including the timely release of radiopharmaceutical products for a reliable supply chain.
  • Ensures deviations, CAPAs, Change Controls, and Product Quality Complaints are timely and properly investigated, providing quality, compliance, and technical expertise.
  • Serves as Subject Matter Expert for assigned Quality Processes and during Health Authority inspections, while strengthening the quality culture through coaching and training.

Matching Summary

Responsible for ensuring the quality of products and compliance with regulatory requirements and cGMP, including the timely release of radiopharmaceutical products for a reliable supply chain.

Skills & Requirements

Must-have

  • Quality oversight for operational activities
  • Ensure compliance with Dutch Law
  • GMP-compliant system implementation
  • Release of radiopharmaceutical products
  • Batch analysis release
  • Investigate deviations and CAPAs

Nice-to-have

  • Agile mindset and collaboration
  • Strengthen quality culture
  • Digital saviness
  • Smart risk taking
  • Dealing with ambiguity

Key Requirements

  • Master Degree in scientific disciplines
  • +3 years of experience in QA
  • Fluent in English

Work Rights

Not specified

Tailored Resume

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