Support for Analytical method data collection and collation, Analytical Method Transfers, both internally and externally to CMO’s/Third Party Laboratories.
• Check of existing analytical methods and validations and verify against dossiers.
• Verify test methods in use and update them for use in receiving sites, as appropriate
• Ensure that the correct instruments are purchased
• Transfer standard operating instructions
• Communicate with and transfer analytical methods from the location to CMO’s/third party labs, as appropriate.
• Support and update (as appropriate) QTA’s with the relevant CMO/third party lab
• Support with method transfer in quality control
• Any other associated tasks for this project (Quality Workstream)