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Novartis Pharma AG
2mo ago

Qualified Person Radiopharmaceuticals(m/w/x)

Nürnberg
Full-timeOn-site

Description

In this role, you will be at the forefront of ensuring the quality and compliance of investigational medicinal products. Daily tasks will involve batch certification, documentation review, and collaboration on quality projects, while also training the next generation of professionals.

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Requirements

  • Qualification as a Qualified Person according to AMG §15
  • Qualification as a Qualified Person for radiopharmaceuticals according to AMG §15 (3a) 5
  • Profound knowledge of pharmaceutical regulations
  • Proactive and self-initiated work style with high sense of responsibility
  • Analytical thinking and flexible, solution-oriented work style
  • Strong organisational and persuasional skills

Education

Master's degree
OR
Doctoral / PhD

Tasks

  • Certify and release batches of investigational medicinal products (IMPs)
  • Certify and release batches of radiopharmaceutical investigational medicinal products (IMPs)
  • Review and approve quality-relevant documentation for batch release
  • Ensure compliance with local and international regulations, especially German Drug Law
  • Continuously improve the quality assurance system and processes
  • Systematically enhance compliance and operational levels
  • Manage corrective and preventive actions (CAPA)
  • Assist in handling complaints
  • Oversee change control management
  • Prepare and review standard operating procedures (SOPs)
  • Manage projects independently
  • Collaborate actively on quality-related projects across teams
  • Train interns and student apprentices

Languages

GermanNative

EnglishBusiness Fluent

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