Job responsibility工作职责
61 Technical Responsibility/技术系职责
61 Lead the QA release team, focus on site management and process control.
领导QA放行团队，关注现场管理和过程工艺控制。
61 Implementation of cGMP assessments and oversight in Manufacturing, QC, Warehouse, facility and utility, including supporting to handle deviations (OOS/OOT/MDD)/change control/CAPA in the above areas from the perspective of QA.
在生产/QC/仓库/公用工程设施区域进行cGMP合规角度的评估和现场管理，包括从QA角度支持解决这些区域发生的偏差（OOS/OOT/MDD）/变更/CAPA。
61 Responsible for material management. Including the material introduction, testing record review, material release and etc.
负责物料的管理工作，包括物料的引入、物料检验记录审核、物料放行等.
61 Review deviations (OOS/OOT/MDD), and support to review change control /CAPA;
主导审核偏差（OOS/OOT/MDD），并支持体系部分的变更/CAPA审核；
61 Carry out batch record and testing record final review. Ensure compliance of the batch documentation in order to support product release.
对批生产记录和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 Carry out QC project documents and records review, Ensure compliance of the documentation and records, and the deliver timely and exactly.
负责QC项目文件和记录的审核，确保文件和记录的合规性以及正确、及时的交付。
61 Participate in internal audits at the company level.
参与公司级别的内审。
61 Write, review and update documents in Chinese and English to establish and maintain efficient operation of the Company’s QA oversight relevant documents and other cGMP documents.
用中英文起草、审核和升级文件，建立和维护QA现场管理相关文件和其他cGMP文件的高效运营。
61 Ability to make accurate judgements and respond in a timely manner to minor and moderate risk quality events occurring/identified on site; ability to identify issues that are out of control and escalate them immediately;
能够对现场发生/发现的较小风险和中等风险的质量事件做出准确判断和及时应对；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 Management Responsibility/管理系职责
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一定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。
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 Responsible for ensuring company meet cGMP requirements, and comply with the quality SOPs;
负责保证公司遵循现行GMP规范的要求，并遵守公司质量系统SOP规定；
61 Review all cGMP relevant documents and ensure the regulatory compliance;
审核所有相关的cGMP文件，确保其法规符合性；
61 Work with cGMP functional departments to continuously improve quality management level.
与cGMP职能部门共同协作，持续提升质量管理水平。
Qualifications 任职资格
61 Minimum of 5 years responsibility in the management of quality for the manufacture of pharmaceutical products, and Minimum of 3 years responsibility in Biopharma industry experience; Knowledge of global cGMP and regulatory requirements related to material/drug substance and drug product;
至少5年制药行业质量管理经验，至少3年生物制药行业经验; 熟悉与物料/原液/成品相关的cGMP及相应法规的监管要求；
61 Strong working knowledge of current Good Manufacturing Practices (cGMP), and regulatory inspections by government agencies (NMPA/CFDA, US-FDA, and EMA or similar)
熟悉现行版cGMP以及法规检查（NMPA/CFDA, US-FDA以及EMA或类似机构）;
61 Experience preparing technical/complex written materials that are accurate, clear, logical, well organized and grammatically sound；
能够起草技术文件，且内容准确、清晰、有逻辑性、有条理以及语法正确；
61 Expert user of Microsoft Office applications (MS Word, Excel, Outlook);
熟练使用办公软件（Word，Excel，Outlook等）
Preferred Experience/优先考虑
61 Detailed knowledge of Good Manufacturing Practice of China, EU, and USA cGMP related to Quality Management Systems;
较好地理解中国、欧盟和美国质量管理体系cGMP相关的法规；
61 Sound understanding of ICH Quality guidelines, quality of biotechnological products, pharmaceutical quality management, and quality risk management;
对ICH指南有基本的理解：生物制品的质量要求，药品质量管理和质量风险评估；
61 previous exposure to regulatory inspections by government agencies (NMPA/CFDA, US-FDA, and EMA or similar);
接受过国家法规机构的审计（中国NMPA，美国FDA和欧洲药品管理局或其他）；
61 Basic understanding of differences between pharmacopeia of China, USA, and EU related to biological products and critical utilities;
对于生物制品和关键设施相关的药典（中国、美国、欧盟）间的区别有基本的认识；
61 Member of PDA, ASQ or similar.
PDA, ASQ或类似机构的成员。