Main responsibilities职责描述：  The Quality Specialist operates within the China Quality organization, reporting to the Quality Manager (GSP). The role supports GxP and health-regulated activities across the full product lifecycle — from development to commercialization — with a primary focus on GSP/GDP compliance. The position works cross-functionally with local business units, global quality teams, regulatory authorities, and external partners including distributors, importers, and subcontractors. 质量专员在中国质量组织内工作，向GSP质量经理汇报。该职位支持产品全生命周期（从开发到商业化）中的GxP和卫生监管活动，重点关注GSP/GDP合规性。该职位需与本地业务部门、全球质量团队、监管机构以及经销商、进口商和分包商等外部合作伙伴进行跨职能协作。 Main Accountabilities 职责描述  Management of the Quality System 质量体系管理：  Define, implement, manage and control Quality system for GxP and health-regulated activities from development to commercialisation of all products and related GxP services, in compliance with Sanofi quality documents and standards, as well as applicable local regulatory.定义、实施、管理和控制GxP和卫生监管活动的质量体系，覆盖所有产品和相关GxP服务从开发到商业化的全过程，确保符合赛诺菲质量文件、标准及适用的本地法规要求。  Enhance Quality culture & promote Quality mind-set into the governance, working principles and ways of operating (focus on GSP/GDP).强化质量文化，在治理、工作原则和运营方式中树立质量思维（重点关注GSP/GDP）。  Ensure appropriate communication of key messages pertaining to Quality across the organisation, highlighting their possible business impact.确保质量相关关键信息在整个组织内进行适当沟通，强调其对业务可能产生的影响。  Manage GSP/GDP Documents and Records per local regulation and requirements, considering data integrity principles, implement the Documentation Management system per local requirement.按照本地法规要求和数据完整性原则管理GSP/GDP文件和记录，并根据本地要求实施文件管理系统。  GSP/GDP Quality audits and regulatory inspections: GSP/GDP 质量审计和监管检查：  Provide support to ensure continuous audit and inspection readiness.提供支持以确保持续的审计和检查准备状态。  Manage regulatory inspections related to GSP/GDP processes owned by the CQH and provide support and coordination with other GxP functions in regulatory inspections for processes in their respective areas of responsibilities, ensuring contribution of concerned functions at Global level, as needed.管理CQH负责的GSP/GDP流程的监管检查,并在监管检查中与其他GxP职能部门协调配合其各自职责范围内的流程,确保集团总部相关职能部门在需要时提供支持。  Assure that inspections of GSP/GDP are reported by the relevant GxP function in the appropriate company global database.确保GSP/GDP检查由相关GxP职能部门在公司全球数据库中进行适当报告。  According to local specific needs and regulatory requirements, enroll and complete the Sanofi auditor certification program to conduct local audits.根据本地具体需求和法规要求,注册并完成赛诺菲审计员认证计划以进行本地审计。  Evaluate trends in local quality audit findings that may affect the Quality system and communicate audit findings that require improvement to the appropriate global functions.评估可能影响质量体系的本地质量审计发现项趋势,并将需要改进的审计发现项传达给相应的全球职能部门。  Training 培训：  Organise and manage information sharing, training sessions or programs related to processes under the responsibility of the CQH for concerned country associates, according to Sanofi standards and regulatory requirements. 根据赛诺菲标准和法规要求，为相关的分公司员工组织和管理与CQH职责范围内的流程相关的信息共享、培训课程或计划。  Ensure that there are system, process and procedure in place for the management of GxP & health-regulated trainings across the country by each GxP & health-regulated Function (CQH oversight on trainings owned by GxP & health-regulated Functions). 确保每个GxP和卫生监管职能部门在分公司范围内都有管理GxP和卫生监管培训的体系、流程和程序（CQH对GxP和卫生监管职能部门所负责的培训进行监督）。  Country Quality Review 质量回顾：  Carry out an annual Country Quality Review and organise the related meeting to present the outcomes to Country Senior Management, as per global Sanofi requirements. 根据赛诺菲总部要求，开展年度分公司质量回顾并组织相关会议，向公司高级管理层展示结果。  Issue the associated Annual Country Quality Review report and monitor the related Quality Program and Action Plan follow-up. 发布相关的年度分公司质量回顾报告，并监控相关的质量计划和行动计划的跟进。  Deviation and Corrective-Preventive Actions (CAPA) management 偏差和纠正预防措施（CAPA）管理： define and implement a process to timely manage deviations and CAPAs related to all GxP and health-regulated activities, including those related to audits and country inspection findings, across the country in a consistent manner, and train concerned associates accordingly. 定义并实施一个流程，以一致的方式及时管理与所有GxP和卫生监管活动相关的偏差和CAPA，包括与审计和分公司检查发现项相关的偏差和CAPA，并相应地培训相关员工。  Change Control management 变更控制管理： set a process to manage proposed changes that may impact GxP or health-regulated process or operations by leading multidisciplinary exchanges, implementing risk assessment and action plans when necessary 通过领导多学科交流、必要时实施风险评估和行动计划，设定一个流程以管理可能影响GxP或卫生监管流程或运营的拟议变更。  Self-inspection 自检/内审： Implement self-inspection per approved plan as auditor or auditee. 作为审计员或受审方按照批准的计划进行自检查/内审。

Experience 工作经验  1-3 years plus working experience in pharmaceutical industry, preferable in MNCs GSP/GDP/GMP area. 制药行业1-3年及以上的工作经验，有跨国药企GSP/GDP/GMP领域工作经验更佳；  Experience in interacting with health authorities, industry associations. 有与卫生监管部门，行业协会互动的经验；  Some QC experience in Bio-Pharm product is plus. 具有生物制药产品质量控制经验者更佳。  A Licensed Pharmacist is a plus, 持有药剂师证者更佳 Education 教育背景  Bachelor's degree or above in Pharmacy, Medicine, Biology, Chemistry or related subjects, OR junior or above professional technical title in Pharmacy. 具有药学或者医学、生物、化学等相关专业大学本科及以上学历或者具有药学初级以上专业技术职称。  Soft skills 通用技能 Good communication skills. 良好的沟通能力  Technical skills 专业技能 GxP and health-regulated Regulations (GMP, GDP). 生产质量管理和经营质量管理Basic 基础 Languages 语言 Fluent in Chinese and English reading, speaking and writing. 能够熟练地应用中文和英文进行书面和口头的阅读理解、写作、交流