Batch Release Lead - Beijing

该职位来源于猎聘 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 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) Analyze performance metrics and escalate in case of issues (I) 分析绩效指标并在出现问题时上报 (I) Informing senior management about batch release performance metrics and trends to support data-driven decision-making (I) 向高级管理层汇报批次放行绩效指标和趋势，以支持数据驱动的决策 (I) Approve actions taken during Quality Alert meeting (D) 批准质量警示会议上采取的行动 (D) Advise on complaint investigation (A) 就投诉调查提供建议 (A) Qualifications for job posting 任职资格:

• 5 years of experience in a QA role within the pharmaceutical industry, with a focus on batch release processes

5 年制药行业 QA 职位工作经验，专注于批次放行流程

• 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

能够有效地调查和解决与批次放行流程相关的问题或偏差

• Experience in managing multiple tasks and projects simultaneously, ensuring timely completion of batch release activities 同时管理多个任务和项目的经验，确保及时完成批次放行活动 Language 语言： Chinese and English中文和英文