崗位職責:
1.負責相關樣品的制劑處方開發和優化工作,完成實驗記錄的規范書寫(制劑處方包括但不限于:凍干制劑、液體制劑)。
Responsible for the formulation development and optimization of relevant samples, and complete the standard writing of experimental records (formulation includes but is not limited to freeze-dried formulation and liquid formulation).
2.負責起草相關文件,包括工藝規程、儀器操作等。
Responsible for drafting relevant documents, including process regulations, instrument operation, etc.
3.負責制劑處方的調研,設計,撰寫及優化。
Responsible for the research, design, writing and optimization of preparation prescriptions.
4.參與制劑成本的核算。
Participate in the cost accounting of preparations.
5.負責管理、維護保養檢驗設備,確保檢驗設備可正常運行且在有效期內。協助主管完成對新設備的安裝、調試、校準、確認以及設備檔案的建立工作。
Responsible for the management and maintenance of the inspection equipment to ensure that the inspection equipment can operate normally and within the validity period. Assist supervisor to complete the installation, debugging, calibration, confirmation of new equipment and the establishment of equipment files.
6.完成制劑主管分配的其他工作和職責。
Complete other work and duties assigned by the preparation supervisor.
7.負責保證所有的活動符合GMP/GLP的要求。
Be responsible for assuring that all the activities are in line with GMP/GLP requirement.
8. 起草制劑相關的驗證文件。
Draft the validation documents related to the product.
任職要求:
1. 至少三年以上從事制劑相關工作(至少包括凍干制劑、液體制劑)的實踐經驗。
At least three years of practical experience in formulation related work (at least including lyophilized preparation, liquid preparation).
2. 能夠閱讀相關的英文資料。
Be able to read related English materials.