Build up of reference data base according to impurity standards in collaboration with Data Management Team
Plan, execute, and report impurity profiles and impurity-based comparability studies for manufacturing process changes and process transfers
Support in information gathering of product and process knowledge (generation of flowcharts, deviation history, etc.)
Support in defining and organizing future sample management procedure
Support definition and alignment of impurity profile analytical testing program
Prepare presentations to support investigations related to process changes, process improvements, deviations/quality issues, and general impurity knowledge
Support global regulatory affairs in impurity profile field by updating impurity chapters in registration dossiers and responding to inquiries from authorities