Flexible Work, Better Balance
Key Responsibilities
Quality & Sterility Assurance
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.
Develop, implement, and maintain a comprehensive sterility assurance program/roadmap, including accountability for the MU’s Contamination Control Strategy.
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.