工作职责:

高级原液上游操作员需要按照现行GMP标准及生产标准操作规程的要求下，能够完成制剂原液的上游细胞培养相关的以下其中一项生产操作任务并且能在此项工作中培训新人，包括但不限于培养基制备，细胞株复苏，摇瓶接种，WAVE反应器操作，XDR生物反应器操作及连续流离心机的操作。

The senior DS upstream operator is responsible for the execution of one of upstream cell culture related tasks needed to produce biopharmaceuticals under current "Good Manufacturing Practices" (cGMP) and in accordance with Standard Operating Procedures and train the new staff, include but are not limited the following activity: the media preparation, cell bank vial thaw, shake flask inoculation, WAVE bioreactor operation, XDR bioreactor operation and continue centrifuge operation.

？ 在SOP的指导下，进行以下其中一项原液的上游细胞培养生产操作。包括但不限于以下生产活动：培养基制备，细胞株复苏，摇瓶接种，WAVE反应器操作，XDR生物反应器操作及连续流离心机的操作。

Perform one of DS upstream cell culture manufacturing under standard operation procedure, include but are not limited the following activity: the media preparation, cell bank vial thaw, shake flask inoculation, WAVE bioreactor operation, XDR bioreactor operation and continue centrifuge operation.

？ 熟悉其中一项细胞培养工作并且培训新人。

Familiar with one of DS cell culture manufacturing and train the new staff.

？ 在SOP的指导下，能够对以上相关生产设备进行清洗及简单的维护工作。

Perform the cleaning and maintenance procedure of related equipment under SOPs.

？ 在生产主管的指导下，能够协助编写标准生产规程。

Edits/write SOPs as directed by the production supervisor.

？ 按照SOP要求进行相应的取样操作及数据记录。

Sampling and data recording based on SOPs.

？ 按时完成被分配的培训项目并通过考核

Ensure to complete the training curricula on time and pass the learning assessment.

？ 为保证新产品、新设备与新工艺顺利实施，在他人指导下参与新产品试制和新设备的调试

Participate the new product technical transfer and new equipment IQ/OQ as directed by experienced stuff.

？ 可以独立进行所负责岗位仪器设备的操作.

Operating independently related instrument and equipment in responsible working area.

？ 有效进行日常的设备使用、清洁、维护，使设备处于有效运行与管理之中，能够判断简单设备故障。

Perform an effective device for routine use, cleaning, maintenance, ensure equipment works normally and be well managed. Judging simple equipment failure.

？ 熟悉工厂日常工作基本的安全规程，能够识别潜在安全隐患。

Observe the plant daily basic safety procedure, identify potential safety hazards.

？ 为了符合GMP、工厂规程要求，正确、及时地完成要求的文件记录。

According to GMP and PQS requirement, proper and timely completion of required documentation.

？ 为了完成团队共同目标，团结团队中其它员工，达成共同目标、对本岗位工作提出有效的改进建议、参与组织团队活动、提出并实施持续改进项目。

In order to accomplish the common goal of the team, united team of other employees to achieve common goals, Provide effective recommendations for improvement and actively participate in team activities, make continuous improvement suggestions.

任职资格:

教育程度/经验 Education/Experiences

？ 高中以上学历，药剂/药学相关专业。

At minimum high school diploma is required, Biotech/pharmacy/Chemistry or equivalent major.

？ 5年以上相关工作经验。

At least 5 years relevant working experience in related environment.

特别知识/技能 Specific Knowledge & Skills

？ 良好的口语和写作沟通能力、有一定的英语和计算机基础知识、具有团队合作精神

Good oral and written communication skills are required. Skill of English and computer, a good team player

？ 了解GMP相关知识，国家药品法规，劳动法、环保法等。

Know GMP knowledge, national drug regulations, labor law, environmental law etc.

上班地址：工厂