Job title职位名称: Batch Release lead 批次放行负责人
About the job工作职责
We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Your job, as Batch Release lead within our M&S China-BEI Site, will be to making best class medicines with excellent strategies and tools and delivering them to our patients.
We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?
Main Accountabilities
主要职责
Overseeing the batch release process to ensure compliance with regulatory requirements and company standards
监督批次放行流程，确保符合法规要求和公司标准
Overseeing review and approval of batch records and associated documentation
监督批次记录及相关文件的审核和批准
Ensuring all batch release activities comply with Good Manufacturing Practices (GMP)
确保所有批次放行活动均符合良好生产规范 (GMP)
Conducting risk assessments and implementing mitigation strategies for batch release processes
对批次放行流程进行风险评估并实施缓解策略
Participating to coordination of actions across teams (Quality Control, production) to ensure lot release in a timely manner following flow controller priorities
参与协调各团队（质量控制、生产）的行动，确保按照流程控制优先级及时放行批次
Investigating and resolving any issues or deviations related to batch release (including temperature excursion evaluation per product if distribution channel faces an unusual event)
调查并解决与批次放行相关的任何问题或偏差（包括在分销渠道遇到异常情况时，对每个产品的温度偏差进行评估）
Participating in internal and external audits and inspections
参与内部和外部审计及检查
Collaborating with regulatory affairs to ensure compliance with local and international regulations
与法规事务部门合作，确保符合当地和国际法规
Monitoring and analyzing batch release performance metrics 监控和分析批次放行绩效指标
Implementing continuous improvement initiatives to enhance batch release efficiency and effectiveness
实施持续改进计划，以提高批次放行的效率和效果
Participating in Quality Alert/Product Alert meetings and ensuring that investigation and actions taken during those meetings allow the decision for disposition of lots
参与质量警报/产品警报会议，并确保会议期间的调查和采取的行动能够为批次处置决策提供依据
Representing the site in the CoP led by global and, if requested, participating in the CoE and ensuring local communication
代表工厂参加由全球领导的实践中心 (CoP)，并根据要求参加卓越中心 (CoE) 的会议并确保与当地沟通顺畅
Point of contact within operational team for complaint investigation when needed on site (coordination of investigation report)
必要时作为运营团队内部投诉调查的联络人（负责协调调查报告撰写）
Approve documents, such as SOPs, etc.
文件审批，例如SOP等
Approve the quality event such as deviation/lab investigation etc.
批准偏差、实验室调查等质量事件
As a change QA expert, participate in the change assessment of Amaryl manufactured at the Hangzhou site.
作为变更QA专家，参与杭州工厂生产的亚莫利产品的变更评估。
Key Roles (D,A,I)
关键角色（D/A/I）
Approve documentation for batch disposition and update corresponding digital tool to allow release (D)
批准批次放行文件并更新相应的数字化工具以允许放行 (D)
Implement risk mitigation strategies to address potential quality issues in the batch release process (D)
实施风险缓解策略以解决批次放行过程中潜在的质量问题 (D)
Resolve issues and deviations and take disposition decision on lots (D)
解决问题和偏差并对批次做出处置决定 (D)
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:
- 5 years of experience in a QA role within the pharmaceutical industry, with a focus on batch release processes and QA management
5 年制药行业 QA 职位工作经验，专注于批次放行流程和QA管理
- 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
- Ability to meticulously review batch records and documentation to ensure accuracy and compliance with regulatory standards
能够仔细审核批记录和文件，以确保准确性和符合监管标准
- Proficiency in analyzing batch release performance metrics and identifying areas for improvement
精通分析批次放行绩效指标并确定需要改进的领域
- Capability to investigate and resolve issues or deviations related to batch release processes efficiently
Why choose us?
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Bring the miracles of science to life alongside a supportive, future-focused team.
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Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
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Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
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Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.
Pursue Progress. Discover Extraordinary.
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. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue Progress. And let’s discover Extraordinary together.
At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
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