Quality Specialist

Job description

This position is set up to take care of PMS related issues, such as complaint handling, AE handling, recall according to regulation/procedure requirement; take care of QMS related tasks and other tasks assigned by the line manager. 该岗位主要负责上市后监管（PMS）相关工作，包括依据法规/程序要求进行投诉、不良事件处理、执行召回；同时负责质量体系（QMS）相关任务以及直线经理交办的其他工作。 1 PMS related 上市后监管相关: - implemented & improve PMS processes for both local products and imported products； 实施及优化现有进口及国产产品的上市后流程； - Fulfil the PMS activities timeline requirement from regulation & Corporate； 确保上市后相关活动的工作时限满足法规及总部要求 Area of Responsibilities 主要职责： Work with the Sales/Marketing/Technical Service/BO team for complaint & AE handling (collection, evaluation, reporting in global SAP C3 system, investigation as appropriate, following up and closure); complaint process improvement; trend analysis; communication with manufacturing sitesfor complaint related issues.与销售 / 市场 / 技术服务 / BO 团队协作处理投诉及不良事件（包括信息收集，评估，在全球 SAP C3 系统中报告，视情况进行投诉跟进直至关闭；推动投诉流程持续改进；开展趋势分析；并就投诉相关问题与生产厂家进行沟通。 （40%） Be responsible for recall related activities implementation including leading the cross-functional team to implement all recall related activities, making sure all affected products are traced back and returned/destructed with evidence as requested by the authorities. 负责召回相关活动的执行，包括领导跨职能团队执行召回行动事宜，确保所有受影响产品均能被追溯，并按监管机构要求退回或销毁，且保留相应证据。（5%） Be responsible for PRER/Alert preparation. 负责定期风险评价报告及预警报告的准备。（10%） 2 QMS related 质量体系相关 - Document control and support internal and external audit； 文控及支持内外审核； - All initial supplier/product/customer qualification related tasks, to meet GSP requirment 首营相关工作，满足GSP 要求 Area of Responsibilities 主要职责： Document control for QMS and Project Documents, including drafts, changes, review and comments, release, distribution, etc. Support internal and external audit. 负责质量体系（QMS）及项目文件的文档控制工作，包括编制、变更、意见汇总、发布、发放等环节； 支持内外部审计工作。（30%） All initial supplier/product/customer qualification related tasks, to meet GSP requirment 首营相关工作满足GSP 要求。（10%） 3 Other tasks per required 其他任务（根据具体要求） （5%）