Hisun Pharmaceutical (Hangzhou) Co., Ltd. is a wholly-owned subsidiary of Zhejiang Hisun Pharmaceutical Co., Ltd. It is engaged in the R&D and manufacturing of API, veterinary API, food additives and final dosage forms of chemical drugs, and in compliance with the regulations of NMPA, FDA, EU, ICH, WHO, etc.Responsibilities:- prepare and receive the regulatory inspections and customer audits, translation support for the whole audit, organize CAPA response;- organize corporate… Show more Hisun Pharmaceutical (Hangzhou) Co., Ltd. is a wholly-owned subsidiary of Zhejiang Hisun Pharmaceutical Co., Ltd. It is engaged in the R&D and manufacturing of API, veterinary API, food additives and final dosage forms of chemical drugs, and in compliance with the regulations of NMPA, FDA, EU, ICH, WHO, etc.Responsibilities:- prepare and receive the regulatory inspections and customer audits, translation support for the whole audit, organize CAPA response;- organize corporate self-inspection;- review quality agreement and complete customer's supplier questionnaire;- organize the management of change control, complaint, return, recall, rework and reprocess, and maintain them with current regulations;- organize the implementation of ISO 9001 Quality Management System;- organize quality review assessment;- revise Site Master File and Quality Manual;- organize the establishment and updating of corporate SOPs. Show less

Responsibilities:- responsible for daily communication with client as contact person;- follow up the validation of facilities, equipment, process and analytical method;- support translation for video meetings;- cooperate with FSSC 22000

- responsible for physical and chemical tests of API/intermediate, including HPLC, IR, UV, K.F., IPC, partical size, etc.;- validate analytical methods of product;- report and investigate QC deviation, OOS/OOT or any abnormities;- cooperate with date integrity inspection;- cooperate with computerized system validation;- organize the management of sample, retention sample;- organize the implementation of product stability test;- organize the management of temperature… Show more - responsible for physical and chemical tests of API/intermediate, including HPLC, IR, UV, K.F., IPC, partical size, etc.;- validate analytical methods of product;- report and investigate QC deviation, OOS/OOT or any abnormities;- cooperate with date integrity inspection;- cooperate with computerized system validation;- organize the management of sample, retention sample;- organize the implementation of product stability test;- organize the management of temperature and humidity of rooms and cabinets;- review the test batch records and issue certificate of analyse. Show less