Pfizer Senior Drug Substance Operator/ in Hangzhou Plant, China

  • 在SOP的指导下,进行原液的生产操作。包括但不限于以下生产活动:培养基/缓冲液制备,细胞接种操作,生物反应器操作,过滤设备操作,层析系统和超滤洗滤系统操作等。Perform DS manufacturing under standard operation procedure, include but are not limited the following activity: Media/Buffer preparation, cell inoculum, bioreactor, filtration equipment, chromatography skids and UF/DF skid.

  • 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;确保进行员工在岗培训,可对其他员工进行工艺操作和设备运行培训。Ensure to complete the training curricula on time and pass the learning assessment. Ensure the in-service training, Training Other employees process operation and equipment operation

  • 为保证新产品、新设备与新工艺顺利实施,参与新产品试制和新设备的调试并能熟练掌握生产工艺并理解工艺原理。Participate the new product technical transfer and new equipment IQ/OQ and Proficiency in the production process and understand the process principle.

  • 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.

  • 遵守公司有关EHS的政策和规定,了解并遵守工厂日常工作基本的安全规程;对生产过程、设备运行、工厂设备的安全检查和安全审计等的安全性提出建设性意见、参与事故调查。Comply with EHS requirements, observe the plant daily basic safety procedures; Give suggestion to safety inspection and safety audit of production processes, equipment operation, factory equipment. Participate in accident investigation.

  • 为了保证生产的安全进行,保证生产现场清洁卫生,符合国家及公司要求,遵守相应的管理措施。In order to ensure the safety of production, keep the production site cleaning, according to the GMP and PQS requirement, compliance with management measures

  • 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并指导他人。According to GMP and PQS requirement, proper and timely completion of required documentation and instruct others.

  • 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.

C:Plant Clock Standard - 标准工时制 (China)

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