Person-in-Plant for a leading innovative US biotech firm at their main European contract manufacturing partner


Provide technical and compliance support on-site during critical steps of the pre-PPQ and PPQ runs of a complex and highly innovative synthetic active pharmaceutical ingredient


  • Successful integration with the local manufacturing and QA teams while providing real-time support as well as communication to the sponsor’s expert teams
  • Timely completion of the PPQ runs
  • Hands-on investigations of deviations; contribution to several improvements
  • Support to the cleaning validation strategy
  • Preparation of several source documents supporting the validation reports