Project phase & Start-up phase????????? Support project team to complete the installation, commissioning and qualification for related equipments. ?????????????????????? Support process engineer to complete equipment acceptance and validation. ??????????????????? Responsible for cleaning of related operation rooms and storage rooms. ???????????????? Routine production phase?????? Equipment operation ???? Excipients dispensing ???? Perform excipients dispensing. ???????? Support excipients charging. ???????? Double check the mixed powder weight in IBC. ?????????????? API dispensing ???? Conduct the material staging according to the production plan. ??????????? Perform API dispensing. ???????? Double check the API weight in IBC. ???????????? Perform excipients charging. ???????? Double check the mixed powder weight in IBC. ?????????????? Granulation ?? Prepare the bonder solution according to the production plan. ????????????????? Conduct the granulation according to the production plan. ??????????? Take samples from granules. ???????? Perform IPC test during granulation. ????????????? Excipient (external addition) weight adjustment. ????????? Blending & Transportation ????? Granules blending. ????? Conduct the material staging according to the production plan. ??????????? Conduct the material transportation. ???????? Tableting ?? Conduct the tableting according to the production plan. ??????????? Take samples from nucleus tablets. ???????? Perform IPC test during tableting. ????????????? Coating ?? Prepare the coating solution according to the production plan. ??????????????? Conduct the coating according to the production plan. ??????????? Take samples from coated tablets. ????????? Perform IPC test during coating. ????????????? Encapsulation ?? Conduct the encapsulation according to the production plan. ????????????? Take samples from capsules. ???????? Perform IPC test during encapsulation. ??????????????? Visual inspection ?? Conduct the visual inspection according to the production plan. ??????????? Deal with the write-off samples of each batch. ??????????? Washing ?? Perform bin washing ?????? Perform equipment parts washing ???????? Cleaning ?? Support bin washing ?????? Support equipment parts washing ???????? General ???? Perform related equipment cleaning and parts manual cleaning. ??????????????????? Participate in 3-shift model. Adjust off day according to production requirement. ???????????????????? System operation ???? MES, PI and CHRIS systems operation MES?PI?CHRIS???? Other operation related to MES, PI and CHRIS systems ??MES?PI?CHRIS??????? Room clearance ???? Manufacturing related ?????? Responsible for cleaning of related operation rooms and storage rooms. ??????????????? Cleaning ?? Routine cleaning in public area. ?????????? Perform monthly-cleaning and qu arterly-cleaning of public area. ????????????????? Take the responsibility of getting consumables in SHiP II. ???????II????????? Documentation ?? Fill in the information for batch record, logbook and other record completely, accurately and timely. ????????????????????????