Job responsibility 工作职责61 Responsibilities of supervisor of downstream process team下游工艺组主管职责
1. Master and operate all downstream production equipment熟练掌握和操作所有下游生产设备
2. Complete the training of all SOPs in the downstream workshop, participate in the company level document system training, and draft the annual training plan of the downstream process team.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，制定下游工艺组年度培训计划。
3. Coordinate resources to ensure the smooth completion and delivery of downstream production projects协调资源使下游生产顺利的完成交付。
4. Be responsible for the maintenance of downstream key equipment负责下游关键设备的维护。
5. Lead and train downstream team members, and draft career development plans for downstream production personnel带领和培养下游团队人员，为下游生产人员制定职业发展计划。
6. Draft batch production records according to SOP documents.按照工艺规程文件起草批生产记录。
7. Team work, maintain team stability, and control the overtime of production personnel. And set up a regular face-to-face communication plan团队协作，维护团队稳定，控制生产人员的加班时间。并设置定期的面对面的沟通计划。8. Lead the team to complete the production of customer projects.带领本团队完成客户项目的生产。9. Can communicate internally and externally, and report production data and results.可以对内，对外沟通，汇报生产的数据和结果。10. Sort out the information required by other departments, such as consumables information, production summary information, etc.整理其他各板块需求的信息，如耗材信息，生产总结信息等。61 Responsibilities of supervisor of downstream support team下游生产支持组主管职责
1. Assist in establishing the documentation system of the production workshop.协助建立生产车间的文件体系。
2. Complete the training plan for workshop personnel and establish personnel files for workshop personnel.完成生产车间人员的培训计划，为生产车间人员建立人员档案。
3. Complete the training of all SOPs in the downstream workshop, participate in the company level document system training, and draft the annual personal training plan of the downstream workshop.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，制定下游车间个人年度培训计划。
4. Collect and sort out or draft the validation documents of equipment, and draft the annual calibration plan of production equipment. Cooperate with the Validation department to complete the risk assessment of the equipment收集和整理或起草设备的验证文件，制定生产设备年度校准计划。配合验证部门完成设备的风险评估工作。
5. Be responsible for the upgrade and drafting of SOP in the downstream production workshop.负责下游生产车间sop的升级，起草。
6. Be responsible for the collection and verification of production batch records and equipment use logs, and supervise production personnel to complete the writing of records on time and accurately and meet the requirements of GDP.负责生产批记录和设备使用记录的收集和核对工作，并督促生产人员按时准确的完成记录的书写并符合GDP的要求。
7. Be responsible for handling the deviation of the production workshop, and regularly organize meetings to summarize and review the deviation of the workshop.负责生产车间的偏差的处理，定期组织会议对车间出现的偏差进行总结和回顾。8. Be responsible for the implementation of workshop changes负责车间变更的执行9. Team work, maintain the stability of the team, and control the overtime of the group.团队协作，维护本团队稳定，控制本组人员的加班时间。61 Responsibilities of supervisor of downstream compliance group下游合规组主管职责
1. Master and operate all downstream buffer preparation equipment, be familiar with the operation principle of downstream process equipment, and support the process group to assist in completing the production process steps.熟练掌握和操作所有下游辅助组配液生产设备，熟知下游工艺设备操作原理，可以支持工艺组辅助完成生产工艺步骤。
2. Complete the training of all SOPs in the downstream workshop, participate in the company level document system training, and draft the annual training plan of the downstream support group.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，制定下游支持组年度培训计划。
3. Prepare the buffer according to the project plan for the process team, and reduce the production cost by replacing the same level materials.根据工艺组项目计划进行缓冲液的准备，并通过同等物料的替换降低生产成本。
4. Draft the maintenance plan of downstream liquid distribution equipment制定下游配液设备的维护计划。
5. Lead and train the team members of the downstream support group, draft career development plans for the personnel of the downstream production support group, and cultivate the interest of the personnel of the support group in the process.带领和培养下游支持组团队人员，为下游生产支持组人员制定职业发展计划，培养支持组人员对工艺的兴趣。
6. Be responsible for drafting and upgrading batch records of solution preparation负责溶液配制批记录的起草和升级。
7. Team work, maintain the stability of the team, and control the overtime of production personnel.团队协作，维护本团队稳定，控制生产人员的加班时间。8. Lead the team to complete the production of customer projects带领本团队完成客户项目的生产。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 Major in Pharmaceutics, Pharmaceutical Science or related field; 药剂学、药学或者其他相关专业。61 Advanced postgraduate qualification (CS, BS) related to bioprocessing or biopharmaceutical production.相关专业的大专生或本科以上学历。61 CS degree with a minimum of 5~7 years, BS degree with a minimum of 3~5 years of pharmaceutical downstream MFG experience;大专生至少5~7年，本科生3~5年相关下游生产经验；61 Experience in managing staff of at least 2 technical specialists;有过至少2人的管理经验；61 Expert knowledge in downstream MFG related to purification process and cGMP quality request of MAbs and recombinant proteins;具有单克隆抗体和重组蛋白的纯化工艺和cGMP质量要求有一定的了解；61 Advanced computer system skills for Microsoft Office suite (Word, Excel, Powerpoint, Project, Outlook); 熟练使用Microsoft Office办公软件(Word、Excel、Powerpoint、Project、Outlook)61 Thorough practical knowledge of Chemistry Manufacturing and Controls for IND/CTA filing in China, USA and EU.在中国、美国和欧盟的药物制造和控制方面有丰富的实践经验。61 Project management of CMC filing for US, EU, and China cGMP;具有美国、欧盟和中国cGMP方面管理经验；61 Process transfer and qualification for BLA;BLA的转移和资质；61 Sound knowledge of Good Manufacturing Practices including NMPA, PIC/S, and US-FDA guidelines with focus on biologic API production for clinical trials;具备良好的生产实践知识，并注重关于生物产品的临床试验的NMPA、PIC/S和US-FDA法规指南；61 Project management training;具有项目管理能力；61 Formal root-cause analysis training.严谨的问题分析能力。
职能类别：生物工程/生物制药 关键字：sop培训计划设备维护文档体系maintenancedownstream