Job responsibility 工作职责
61 Responsibilities of technician of downstream process team下游工艺组技术员职责
1. Master and operate two downstream key process production equipment
熟练掌握和操作两种下游关键工艺生产设备
2. Complete the training of all SOPs in the downstream workshop and participate in the company level document system training
完成下游车间内部所有SOP的培训，参加公司级别的文件体系培训
3. Assist the buffer preparation personnel to complete material weighing, buffer preparation, pipeline assembly sterilization and filter integrity testing (and can lead interns or assistant technicians to complete the above work).
辅助配液组完成物料称量，配液，管路组装灭菌和滤器完整性检测等工作（并且可以带领实习生或助理技术员完成以上工作）。
4. Fill in batch production records and relevant equipment use and cleaning records on time and accurately as required
按照要求按时准确的填写批生产记录及相关设备使用，清洁记录。
5. Assist the senior production technician to complete the production of a production process step in the downstream production process.
协助生产高级技术员完成下游生产流程中一个生产工艺步骤的生产。
61 Responsibilities of technician of downstream support team下游生产支持组技术员职责
1. Assist the downstream production workshop document team to complete the establishment of the document system
辅助下游生产车间文件组完成文件体系的搭建
2. Lead the assistant technician to familiarize with the workflow
带领助理技术员熟悉工作流程。
3. Be familiar with the workflow of QC, QA, VA, WH, MF and other groups.
熟悉QC,QA,VA,WH,MF等各组的工作流程。
4. Be responsible for the distribution of training records of workshop personnel
负责车间人员培训记录的发放。
5. Be responsible for updating the equipment account of the workshop
负责车间设备台账的更新。
6. Be responsible for the purchase of cGMP materials in the workshop, and be familiar with the MRB purchase process
负责车间cGMP物料的采购，熟悉MRB采购流程
7. Can be the initiator of deviations and changes
可以作为偏差和变更的发起人
61 Responsibilities of technician of downstream compliance group下游合规组技术员职责
1. Master and operate the downstream weighing equipment and perform the annual calibration of the equipment
熟练掌握和操作下游配液称量设备并执行设备年度校准工作。
2. Complete the training of all SOPs in the downstream workshop and participate in the company level document system training
完成下游车间内部所有SOP的培训，参加公司级别的文件体系培训
3. Complete material weighing, liquid dispensing, pipeline assembly sterilization, filter integrity testing and other support work (and can lead interns or assistant technicians to complete the above work).
完成物料称量，配液，管路组装灭菌和滤器完整性检测等支持工作（并且可以带领实习生或助理技术员完成以上工作）。
4. Fill in batch production records on time and accurately as required.
按照要求按时准确的填写批生产记录。
5. Complete the requisition and return of materials required for production.
完成生产所需物料的申领和退库工作。
Safety and environment 现场安全和环境合规
61 Promote a culture of safe work place through personal actions.
以身作则推动建立安全的工作环境。
61 Adhere to the Company’s safety and environmental protection procedures.
遵守公司的安全环保程序。

Quality Assurance 质量要求
61 All pharmaceuticals production and packaging should follow approved process procedures and operation procedures, and the relevant records should be kept in order to obtain products of the requisite quality and be in accordance with the relevant manufacturing and registration requirements.
所有药品的生产和包装均应当按照批准的工艺规程和操作规程进行操作并有相关记录，以确保药品达到规定的质标准，并符合药品生产许可和注册批准的要求。
61 Operation procedures for division of production batches should be established. The batch division should be able to ensure the consistency of product quality and characteristics in the same batch.
应当建立划分产品生产批次的操作规程，生产批次的划分应当能够确保同一批次产品质和特性的均一性。
61 Operations on different kinds of products should not be carried out in the same operation room at the same time unless there is no risk of mix-up or cross-contamination.
不得在同一生产操作间同时进行不同品种和规格药品的生产操作，除非没有发生混淆或交叉污染的可能。
61 At every stage of production, products and materials should be protected from microbial and other contamination.
在生产的一阶段，应当保护产品和物料免受微生物和其他污染。
61 At all times during production, all materials, intermediate product or bulk product, major items of equipment and where appropriate rooms used should be labelled or otherwise identified with an indication of the name, strength and batch number of the product or material being produced, When necessary, this indication should also mention the stage of production.
生产期间使用的所有物料、中间产品或待包装产品的容器及主要设备、必要的操作室应当贴签标识或以其他方式标明生产中的产品或物料名称、规格和批号，如有必要，还应当标明生产工序。
61 Normally, line clearance should be carried out after every production completion, to ensure the equipment and work station are clear of any material, product and document related to this production. Before any processing begins, there should be confirmation on previous clearance.
每次生产结束后应当进行清场，确保设备和工作场所没有遗留与本次生产有关的物料、产品和文件。下次生产开始前，应当对前次清场情况进行确认。
61 Any deviation from instructions or procedures should be avoided as far as possible. If a deviation occurs, it should be handled according to the deviation operation procedure.
应当尽可能避免出现任何偏离工艺规程或操作规程的偏差。一旦出现偏差，应当按照偏差处理操作规程执行。

Qualifications 任职资格
61 Higher degree than CS，BS（Preferably Biology or Pharmaceutical Science）.
大专或本科以上学历 （优先生物或者药学专业）
61 Experience in pharmaceutical manufacturing.
具备药厂生产的相关工作经验。
61 Expert user of Microsoft Office applications (MS Word, Excel, Outlook).
熟练使用办公软件（Word，Excel，Outlook等）。
61 Be familiar with the production process of antibody drugs and have the production experience of antibody drugs.
熟悉抗体药物的生产工艺，具备抗体药物的生产经验。
61 Outstanding graduates from state key universities.
国家重点院校的优秀毕业生