• Support MSAT Validation Expert from Vaxcyte program in the preparation of validation documents: specifically in writing of process validation protocols and validation reports (support MSAT Expert by adding results into reports, taking care of the document layout preparation for archiving documents in DMS system, verification of data, entering results into validation reports, etc.).
  • Supporting during the process validation phase by preparing part of documents of process characterization studies, development studies and validation supporting studies.
  • Support MSAT Validation SME in the preparation of continued process verification plan.
  • Support MSAT Val SME in the preparation of Product Quality Reviews.