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Associate-QA Compliance - Suzhou, 中国 - Lilly
描述
We're looking for people who are determined to make life better for people around the world.
岗位描述 Position Brand Description:
该岗位为工厂合规QA,负责通过构建、完善、执行和监督质量流程来保障工厂质量体系的全面合规性。持续监督本地法规、药品生产质量管理规范以及礼来公司全球质量准则要求的实施,并按适当的管控措施及时上报潜在合规性风险。
This role serves as site Compliance QA, is responsible to ensure the overall compliance of the site quality systems by building, improving, executing and monitoring strong quality process. To monitor for compliance with local regulations, the requirements of GMPs and Lilly Global Quality Standard, and report potential compliance risk in a timely manner through appropriate governance.
主要职能 Key Objectives/Deliverables:
负责收集质量指标的数据,包括每周更新、月度质量指标、质量月度报告等,并及时上报潜在合规性风险。Be responsible for collecting data for quality metrics, including Weekly Update, Monthly Quality Metrics, Quality Monthly Report etc., report potential compliance risk in a timely manner.
负责构建稳健的工厂质量体系,参加总部会议、参与合规相关的偏差调查、与总部业务专家持续沟通及与其他工厂交流最佳实践,以支持工厂合规体系的持续改进。Be responsible to establish the robust site Quality System, participate in global team conference, support compliance continuously improve the compliance system.
作为偏差管理系统负责人As Deviation Management System owner role
负责工厂偏差管理规程的维护,确保符合礼来质量准则和目标市场的法规要求。Maintain the site procedure for DEVIATION MAMAGEMENT, to ensure compliance with the requirements from Lilly Quality Standards and Intended markets regulations.
负责偏差审核会议,并定期对偏差进行趋势分析。Facilitate Review Board, and conduct deviation trend analysis periodically.
作为偏差管理系统的讲师,对工厂员工进行偏差模块各级用户的培训,以及因果关系图、书写技巧等提升培训。As trainer for deviation management system, provide training to the site employees for all deviation module users, and enhance training of Causal Factor Chart and Technical Writing.
作为质量计划协调员 As Quality Plan Coordinator role
负责工厂质量计划规程的维护,确保符合礼来质量准则。Maintain the site procedure for Quality Plan, to ensure compliance with the requirements from Lilly Quality Standards.
协调工厂质量计划的起草及批准,跟踪其实施。Coordinate site quality plan development and approval and follow up the implementation.
其他与质量管理相关的事项,如:To assume other tasks related to QA, such as:
参与偏差调查、变更执行等活动To take part in deviation investigation, change execution etc.
对其他部门提供改进建议和服务To provide good services and recommendations to other departments for improvement
完成主管安排的其他任务Other jobs assigned by supervisor
基本要求 Basic Requirements:
本科及以上学历,药学、化学或相关学科Bachelor degree or above, majored in pharmaceuticals, chemistry or related sciences
至少在制药行业 5年的经验,其中 1年以上的生产经验及2年以上的 QA经验At least 5 years experience in pharmaceutical industry, including at least 1year operation experience and 2 years QA experience,
良好的沟通和协调能力Good communication and coordination skill
能够用英文流利地进行沟通以及读写,熟练使用Word, Excel, PPT等办公软件Capable of speaking, writing and read in English in fluency, and computer skills, especially in Word, Excel and PPT.
Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
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