QA Specialist

Job Information 职位信息

Job title职位名称: QA Specialist QA专员

• Location工作地点： Beijing, China 中国北京
• % Remote working and % of travel expected 远程办公和出差的概率：N/A
• Job type工作类型: Full time全职
• Site/Unit 区域/事业部：Beijing Site/ M&S China北京工厂/中国制造与供应事业部 

About the job工作职责

Our Team我们的团队：
The M&S division encompasses manufacturing platforms built on 3 global business units, along with supporting functions including Quality, Supply, and Lean Strategy. It is dedicated to manufacturing high-quality medicines and delivering them to patients through outstanding strategies and tools.

制造与供应事业部包含以3个全球事业部为基础的制造平台，以及质量、供应商、精益战略等支持部门，致力于用优异的战略和工具制造优质的药品并传递到患者手中。

•    Ensure all distribution and marketing activities of products operated by Sanofi entities in China are in compliance with Sanofi Quality Policy, Quality Standards and applicable regulatory requirements.确保赛诺菲在中国运营的所有产品的分销和营销活动符合赛诺菲质量政策、质量标准及适用的法规要求。
•    Manage quality processes and perform quality control activities as defined in procedures, especially those established in accordance with current GSP/GDP regulations.管理质量流程并执行程序中定义的质量控制活动，特别是根据现行GSP/GDP法规建立的相关活动。
•    Provide strong quality support to innovation and business initiatives, including digital transformation projects. 从质量角度为创新和业务举措（包括数字化转型项目）提供有力支持。
•    Promote a quality culture and quality mindset across the organization, ensuring compliance with both global Sanofi standards and local Chinese regulatory requirements. 在整个组织中推广质量文化和质量思维，确保符合赛诺菲全球标准和中国本地法规要求。

Main responsibilities职责描述：
主要职责

•Ensuring that activities in his/her scope are conducted in compliance with applicable regulatory requirements 
确保其范围内的活动按照适用的监管要求进行 

• Ensuring compliance with Good Manufacturing Practices (GMP) and other relevant regulations 
确保符合药品生产质量管理规范 （GMP） 和其他相关法规 

• Conducting regular audits of production processes to identify and address potential quality issues 
对生产流程进行定期审计，以识别和解决潜在的质量问题 

• Collaborating closely with production to ensure quality standards are maintained throughout the product lifecycle; highly recommended to be located on the shopfloor 
与生产部门密切协作，确保在整个产品生命周期内保持质量标准；强烈建议位于车间

• Managing and resolving quality-related issues in a timely and effective manner 
及时有效地管理和解决质量相关问题 

• Monitoring and analyzing quality performance metrics, implementing corrective actions as needed 
监控和分析质量绩效指标，根据需要实施纠正措施 

• Leading root cause analysis investigations for quality incidents and implementing preventive measures 
领导质量事故的根本原因分析调查并实施预防措施 

• Participating in internal and external audits and regulatory inspections providing support and documentation 
参与内部和外部审计和监管检查，提供支持和文件 

• Reviewing batch records and associated documentation 
审核批记录和相关文件 

• Developing and implementing risk management strategies to mitigate potential quality issues 
制定和实施风险管理策略，以缓解潜在的质量问题 

• Fostering a culture of quality and continuous improvement across the organization 
在整个组织内培养质量和持续改进的文化

•Participate in deviation, complaint, and change control processes, demonstrating high independent judgment in timely identification, investigation, and resolution of deviations and complaints that may impact product quality; participate in initiating corrective and preventive actions, support CAPA implementation and verify CAPA effectiveness. Reviewing batch records and associated documentation. 
参与偏差，投诉和变更流程，在及时识别、调查和解决可能影响产品质量的偏差和投诉方面，表现出较高的独立判断力；参与发起纠正和预防措施，支持CAPA的实施并检查CAPA的有效性。 

•Review batch records and associated documents to ensure accuracy and compliance; draft and revise quality-related procedures and standard operating procedures(SOPs). 
审核批记录和相关文件,起草修订质量相关规程。 

•CMO management : Conduct on-site inspections of the CMO 
CMO 管理：对CMO进行现场检查 

•Complete product quality review to ensure that PQR is completed in a timely manner in accordance with the corresponding procedures and GMP requirements. 
完成产品质量回顾，确保PQR 按照相应的程序和GMP 要求及时完成。

Key Roles (D,A,I) 
关键角色（D/A/I）

•Request corrections when GMP rules are not respected (D) 
未遵守 GMP 规则时请求更正 （D） 

• Prioritize quality and compliance objectives (A) 
优先考虑质量和合规目标 （A） 

• Proactively implement remediation action from findings from internal and external audits related to quality issues (D) 
积极实施来自内部和外部审计缺陷的与质量问题相关的补救措施 （D） 

• Request quality improvement initiatives and strategies (D) 
请求质量改进计划和策略 （D） 

• Identify discrepancies and corrective/preventive actions that need to be taken (D) 
确定需要采取的差异和纠正/预防措施 （D） 

• Escalate to upper management any failure in GMP execution on shopfloor (I) 
在车间 （I） 将 GMP 执行失败的情况上报给高级管理层 

• Inform relevant stakeholders and team members of quality performance, corrective actions, findings, and preventive measures (I) 
将质量绩效、纠正措施、发现和预防措施告知相关利益相关者和团队成员 （I）

• Advise on how to present a topic and answer specific questions (A) 
就如何展示主题和回答具体问题提供建议 （A） 

• Advise on risk management strategies and plans (A) 
就风险管理策略和计划提供建议 （A） 

• Advise on initiatives to promote a quality-focused culture (A) 
就促进以质量为中心的文化的举措提供建议 （A） 

• Approve a batch record if it is correctly completed and meets the quality requirement for one lot (D) 
如果正确完成批记录并满足一个批次 （D） 的质量要求，则批准该批记录 

• Check whether all practices are done according to quality requirement; if not, assure that a deviation is opened and reported in the batch record (D) 
检查是否按照质量要求完成所有操作；否则，确保在批记录 （D） 中打开并报告偏差 

• Review documentation for batch disposition (A) 
审核批处置文档 （A）

Additional Accountabilities 
额外的职责

HSE: 

• Responsible for following the company’s HSE policy and integrated all requires into daily work. Incorporate HSE work into the work plan 
负责贯彻公司 HSE的有关规定，把公司 HSE制度的措施贯彻到每个具体环节。将 HSE工作纳入工作计划中。 

• Participate the implementation of HSE management target plan of this department, implement HSE rules and regulations, HSE operation procedures and HSE technical action plan
参与实施本部门 HSE管理目标计划，落实 HSE规章制度、HSE操作规程和 HSE技术措施计划。

About you 任职资格:
Expected Experience预期经验： 

• Minimum of 3 years experience in quality assurance within the pharmaceutical industry 
至少 3年制药行业质量保证经验 

• Strong knowledge of Good Manufacturing Practices (GMP) and quality assurance principles 
熟悉良好生产规范 （GMP） 和质量保证原则 

Expected Technical skills预期的技术技能： 

• Ability to analyze complex data and identify trends, issues, and solutions 
能够分析复杂数据并确定趋势、问题和解决方案 

• High level of accuracy and attention to detail in all quality assurance activities 
在所有质量保证活动中高度准确并注重细节 

• Strong verbal and written communication skills for effective interaction with team members and regulatory bodies 
较强的口头和书面沟通技巧，能够与团队成员和监管机构有效互动 

• Proficiency in identifying problems and implementing effective corrective actions 
熟练识别问题并实施有效的纠正措施 

• Ability to manage multiple projects simultaneously, ensuring timely completion and adherence to quality standards 
能够同时管理多个项目，确保及时完成并遵守质量标准 

Language语言： 
Chinese and English中文和英文

Pursue progress, discover extraordinary 进无止境，探索菲凡

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. 
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. 
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! 
进步，外部可见。更好的药物，更好的效果，更高的科学。但是进步离不开人去创造——来自不同背景、不同地区、担任不同岗位的人。所有人都团结在“创造奇迹的渴望”这一使命下。让我们成为这样的人。
在赛诺菲，不分种族、肤色、血统、宗教、性别、国籍、性取向、年龄、公民身份、婚姻状况、残疾或性别认同，我们为所有人提供平等的机会。
观看我们的 ALL IN 视频，并在 sanofi.com 网站上查看我们有关多元化、公平性、包容性的举措。
Take The Lead Behaviours：Aim Higher、Act for Patients、Be Bold and Lead Together
引领前行行为：更高目标、以患者为本、勇于创新、共同领导

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!