Quality Management Expert

2 days ago


Malmo, Skåne, Sweden Sever Pharma Solutions Full time
About the Role

The Quality Assurance Manager will be responsible for leading our QA department and ensuring that all aspects of quality assurance are met. This includes:

  • Trending of environmental monitoring results
  • Managing samples/results sent to external labs for microbiological analysis
  • Contact person for external labs handling microbiological tests
  • Participating/planning in Aseptic Process Simulation, APS
  • Participating/planning in Gas Cycle Development, GCD
  • Handling deviations, OOS, Change controls & complaints
  • Writing, reviewing and approving quality documentation
  • Reviewing of batch documentation
  • Release of bulk and intermediates
  • Providing support to other departments within the company

Key Responsibilities

The successful Quality Assurance Manager will have the following key responsibilities:

  1. Leading the QA department and ensuring that all aspects of quality assurance are met
  2. Trending of environmental monitoring results
  3. Managing samples/results sent to external labs for microbiological analysis
  4. Contact person for external labs handling microbiological tests
  5. Participating/planning in Aseptic Process Simulation, APS
  6. Participating/planning in Gas Cycle Development, GCD
  7. Handling deviations, OOS, Change controls & complaints
  8. Writing, reviewing and approving quality documentation
  9. Reviewing of batch documentation
  10. Release of bulk and intermediates
  11. Providing support to other departments within the company


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