Job responsibility 工作职责
61 Technical Responsibility/技术系职责
61 Responsible for the quality management of the company's projects, communicate with customers directly and deal with problems.
负责公司各项目的质量管理工作，直接面对客户进行沟通和问题处理。
61 Responsible for supporting audit from the agency and the customers and resource coordination.
负责配合官方和客户审计，并提供资源。
61 Participate as a key person in internal audits at the company level.
作为主要人员，参与公司级别的内审。
61 Execute company decision, assign quality management task.
公司决策的执行，质量管理任务的分配工作。
61 Lead the operation team, focus on site management and process control.
领导团队，关注现场管理和工艺过程监控。
61 Implementation of cGMP assessments and oversight in Manufacturing, facility and utility, including supporting to handle deviation/CAPA/change control in the above areas from the perspective of QA.
在生产、公用工程设施等区域进行cGMP合规角度的评估和现场管理，包括从QA角度在支持解决这些区域发生的偏差/变更/CAPA。
61 Carry out final review for production records and analytical records. Ensure compliance of the batch documentation in order to support product release.
对批生产记录和批检验记录进行最终审核，确保批次文件的合规性以支持产品放行。
61 Responsible for the releasing of the raw materials.
负责物料的放行。
61 Support qualified person for the batch release, according to the procedures.
按照公司SOP的规定，支持受权人进行批次放行。
61 Review and approve change controls, investigations and procedures, , according to the procedures;
按照公司SOP的规定，审核并批准相应级别的变更、调查、偏差和SOP文件；
61 Clear knowledge of product process and quality control, able to control the risk points in the product and quality system. Ability to make quality decisions to resolve moderately complex issues with minimal assistance from management. Able to recognize when an issue is beyond their sphere of influence and escalates immediately;
对产品工艺和质量控制有着清晰的认知，能够把控产品和质量体系中的风险点，能够做出质量决策，解决复杂的问题，且尽量少的从管理层获得协助。能够识别出超出可控范围的问题并立即升级处理；
61 Additional duties as assigned。
完成其他分配的任务。
61 管理系职责
61 Highly sensitive to events occurring at the company's GMP site, able to make relatively accurate judgements and responses to risks and product impacts in the *** instance. And can dig out the root cause of the incident and guide the development of corrective and preventive measures.
对公司GMP现场发生的事件有高度的敏感性，能够***时间对风险和产品的影响有相对准确的判断和响应。并且能够对事件挖掘出根本原因，并指导制定出纠正和预防措施。
61 Organized manager with strong prioritization and delegation skills;
有组织的领导者，具有很强的优先级和分配技能；
61 Ability to report and communicate with line management on emergencies in a timely manner.
能够与直线领导对紧急事件进行及时的汇报和沟通。
61 Meticulous attention to details and preferred to work in highly structured system to comply with Quality Management Systems;
对于细节的持续关注并且适合在高度严格的系统下工作以遵循质量管理系统的要求；
61 Organized and detail-oriented advocate for quality assurance and continuous improvement.
为质量保证和持续改进的工作具备较高的组织能力和细节处理能力。
61 Enjoy working in highly structured system to execute changes that improve operational efficiency and product quality.
乐于在具有高度组织架构的系统中为提升运营效率和产品质量作出变化。
61 Sound communication skills in Chinese and English to write and review bilingual documents and accurately exchange highly technical information with colleagues, auditors, and suppliers.
良好的中英文沟通能力，能够起草和审核双语文件并且准确地使用技术语言和同事、审计官、供应商进行交流。
61 Interview, mentor, and manage performance of team members;
面试，指导和管理小组成员绩效；
61 Accurately report the on-site GMP status for routine operation and projects;
准确报告公司现场的GMP状态；
61 Work with other departments in the quality system to achieve quality objectives;
与质量体系中其他部门共同达成质量目标；
61 Prepare annual operating and capital budgets for QA release team.
为QA放行部门编制年度经营预算和资本预算。
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；
遵守公司的安全和环境保护程序；
61 Comply with the company's EHS policies and regulations, and complete EHS related work.
遵守公司有关EHS的政策和规定，并完成EHS相关工作。
Quality Assurance 质量要求
61 Work with cGMP functional departments and QU other functions to continuously improve quality management level.
与cGMP职能部门以及质量部其他职能部门共同协作，持续提升质量管理水平。
61 Responsible for ensuring company meet cGMP requirements;
负责保证公司遵循现行cGMP规范的要求;
61 Approve GMP relevant documents with the appropriate level and ensure the regulatory compliance;
批准相应级别的cGMP文件，确保其法规符合性；
61 Participate in the audits by government authorities and clients;
参与政府部门、客户的审计;
61 Represented QA function at internal quality audit and/or regulatory inspection by government agencies).
负责内部质量审核和/或政府机构的监管检查。