1. Leading to construct the site quality management system to guarantee apheresis collectingprocess\drug product thawing and infusion process complied with the GMP requirement.
2. Leading to finish commercial product site qualification to guarantee qualified ATC(apheresis and therapeutic center).
3. Leading to finish deviation investigation of site quality scope.
4. Leading to finish change control assessment and report to regulator if necessary.
5. Leading to write commercial product annual quality review report. related to ATC.
6. Work with Commercial team to guarantee the operation on ATC under control.
7. Provide training and guidance on GMP regulation for Commercial team member.