Main responsibilities职责描述： • 确保其范围内的活动按照适用的监管要求进行 • Ensuring that activities in his/her scope are conducted in compliance with applicable regulatory requirements • 确保符合药品生产质量管理规范 （GMP） 和其他相关法规 • Ensuring compliance with Good Manufacturing Practices (GMP) and other relevant regulations • 对生产流程进行定期审计，以识别和解决潜在的质量问题 • Conducting regular audits of production processes to identify and address potential quality issues • 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 • Collaborating closely with production to ensure quality standards are maintained throughout the product lifecycle; highly recommended to be located on the shopfloor • 及时有效地管理和解决质量相关问题 • Managing and resolving quality-related issues in a timely and effective manner • 监控和分析质量绩效指标，根据需要实施纠正措施 • Monitoring and analyzing quality performance metrics, implementing corrective actions as needed • 领导质量事故的根本原因分析调查并实施预防措施 • Leading root cause analysis investigations for quality incidents and implementing preventive measures • 参与内部和外部审计和监管检查，提供支持和文件 • Participating in internal and external audits and regulatory inspections providing support and documentation • 制定和实施风险管理策略，以缓解潜在的质量问题 • Developing and implementing risk management strategies to mitigate potential quality issues • 在整个组织内培养质量和持续改进的文化 • Fostering a culture of quality and continuous improvement across the organization • 监督批次放行流程，确保符合监管要求和公司标准 • Overseeing the batch release process to ensure compliance with regulatory requirements and company standards • 监督批记录和相关文件的审核和批准 • Overseeing review and approval of batch records and associated documentation • 确保所有批次放行活动符合药品生产质量管理规范 （GMP） • Ensuring all batch release activities comply with Good Manufacturing Practices (GMP) • 进行风险评估并实施批次放行流程的缓解策略 • Conducting risk assessments and implementing mitigation strategies for batch release processes • 参与跨团队（质量控制、生产）的行动协调，以确保按照流量控制器的优先级及时放行批次 • Participating to coordination of actions across teams (Quality Control, production) to ensure lot release in a timely manner following flow controller priorities • 调查和解决与批次放行相关的任何问题或偏差（包括如果分销渠道面临异常事件，则评估每个产品的温度偏差） • Investigating and resolving any issues or deviations related to batch release (including temperature excursion evaluation per product if distribution channel faces an unusual event) • 参与内部和外部审计和检查 • Participating in internal and external audits and inspections • 与监管事务部合作，确保符合当地和国际法规 • Collaborating with regulatory affairs to ensure compliance with local and international regulations • 监控和分析批次放行绩效指标 • Monitoring and analyzing batch release performance metrics • 实施持续改进计划，提高批次放行效率和有效性 • Implementing continuous improvement initiatives to enhance batch release efficiency and effectiveness • 参加质量警报/产品警报会议，并确保在这些会议期间采取的调查和行动能够决定批次的处置 • Attend quality alert/product alert meetings and ensure that investigations and actions taken during these meetings determine the handling of the batch. • 在由全球领导的 CoP 中代表工厂，如果要求，参与 CoE 并确保当地沟通 • Represent the factory in the globally leading CoP, participate in the CoE if required, and ensure local communication. • 运营团队内需要现场进行投诉调查的联系人（协调调查报告） • The contact person within the operations team who needs to conduct on-site complaint investigations (to coordinate investigation reports).

预期经验 Expected Experience • 至少 2 年制药行业质量保证经验 • Minimum of 2 years experience in quality assurance within the pharmaceutical industry • 熟悉良好生产规范 （GMP） 和质量保证原则 • Strong knowledge of Good Manufacturing Practices (GMP) and quality assurance principles 预期的技术技能 Expected Technical skills • 能够分析复杂数据并确定趋势、问题和解决方案 • Ability to analyze complex data and identify trends, issues, and solutions • 在所有质量保证活动中高度准确并注重细节 • High level of accuracy and attention to detail in all quality assurance activities • 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 • Strong verbal and written communication skills for effective interaction with team members and regulatory bodies • 熟练识别问题并实施有效的纠正措施 • Proficiency in identifying problems and implementing effective corrective action • 能够同时管理多个项目，确保及时完成并遵守质量标准 • Ability to manage multiple projects simultaneously, ensuring timely completion and adherence to quality standards 语言 Language • 当地语言和英语 • Local language and English