Sterility Assurance Senior [F/M/X]

Job description

Key Responsibilities

Quality & Sterility Assurance

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  Own the MU’s sterility assurance risk profile, including the transversal strategy to mitigate/remediate risks and continuous improvement of the Sterility Assurance Quality System.

  
  


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  Develop, implement, and maintain a comprehensive sterility assurance program/roadmap, including accountability for the MU’s Contamination Control Strategy.

  
  


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  Monitor and improve manufacturing processes to identify potential sources of contamination and drive CAPA, e.g. via approval of PQ EM reports, facility design assessments, and EM/aseptic/bioburden/endotoxin risk assessments.