工作职责: 1.负责相关样品的制剂处方开发和优化工作,完成实验记录的规范书写(制剂处方包括但不限于:冻干制剂、液体制剂)。 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.负责起草相关文件,包括工艺规程、仪器操作等。 Responsible for drafting relevant documents, including process regulations, instrument operation, etc. 3.负责制剂处方的调研,设计,撰写及优化。 Responsible for the research, design, writing and optimization of preparation prescriptions. 4.参与制剂成本的核算。 Participate in the cost accounting of preparations. 5.负责管理、维护保养检验设备,确保检验设备可正常运行且在有效期内。协助主管完成对新设备的安装、调试、校准、确认以及设备档案的建立工作。 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.完成制剂主管分配的其他工作和职责。 Complete other work and duties assigned by the preparation supervisor. 7.负责保证所有的活动符合GMP/GLP的要求。 Be responsible for assuring that all the activities are in line with GMP/GLP requirement. 8. 起草制剂相关的验证文件。 Draft the validation documents related to the product. 任职资格: 1. 至少三年以上从事制剂相关工作(至少包括冻干制剂、液体制剂)的实践经验。 At least three years of practical experience in formulation related work (at least including lyophilized preparation, liquid preparation). 2. 能够阅读相关的英文资料。 Be able to read related English materials.