Qualified Person

vor 20 Stunden

Munich, Bayern, Deutschland Discover International Vollzeit

We are partnered with one of Germany's most exciting, and innovative Biopharmaceutical companies, who are currently going through a phase of growth. They are expanding their Quality department for their HQ site in Bavaria, and are seeking a Qualified Person to release their Biological products and generally contribute to the strategic direction of the Quality department.

The ideal candidate is a critical thinker that is flexible and can manage working across multiple areas. As a Qualified Person you should bring experience in evaluating processes within the Quality Systems of change management, deviation and CAPA management, and experienced in overseeing Batch release and relevant documentation. This company boast a strong commercial and clinical pipeline for both Small and Large molecule products.

Responsibilities

  • Batch Release and relevant Documentation for Biologics pipeline.
  • Work cross-functionally across multiple relevant departments.
  • Compile Quality Reports and document findings.
  • Qualifying and Managing external Vendors.
  • Perform Root Cause and Risk analysis.
  • Support Internal and External Audits.

Requirements

  • 5+ years' Pharmaceutical QA GMP experience.
  • Sachkundige Person according to AMG 14
  • Clear knowledge of QA Processes.
  • Fluent German + English.
  • Good communicator.
  • Highly organized.

Package

  • Flexible hybrid working model
  • Clear progression Path.
  • Friendly and open company culture
  • Competitive salary package

Reach out via for more details.

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