高级质量专员-投诉调查 杭州

月薪： 1-1.5万/月

该公司所有职位
  • 3-4年经验
  • 本科
  • 招若干人
  • 02-05 发布

职位描述

主要职责: ESSENTIAL DUTIES AND RESPONSIBILITIES: 35% of time or importance1.投诉处理Complaint Investigation :                                                        ?维护投诉处理流程，确保程序严格执行。Maintain complaint handling process, and ensure procedure is executed as procedure.?接收、确认全球投诉处理中心的投诉信息和调查要求。Receive and verify complaint information and investigation requests from global complaint handling units.?评估、上报潜在的不良事件。Evaluate and escalate potential adverse event.?协调质量检验部门完成相关产品的物理、化学、微生物检测。Coordinate QC department to perform related physical, chemical and microbial tests.?执行相关产品、组件的物理检查。Perform physical inspection for products and components.?协调外部检测机构，完成投诉样的物质鉴别。Coordinate external laboratory to perform substance identification of the returned product.?审核批记录，评估是否有投诉相关的物料、产品、工艺方面的变更、不符合和关键参数。Review batch record, and evaluate the change to material, product or process, non-conformance and key process parameter related to complaint.?审核供应商、生产部的投诉调查报告，推动调查及时关闭。Review complaint investigation report from supplier and manufacturing department, lead closure of complaint investigation in a timely manner.?回顾投诉率，建立动态投诉趋势图，评估投诉趋势,发现不良趋势,向管理层报告。Review complaint rate, create dynamic complaint trending chart, and perform trending analysis. If unfavorable trend is discovered, escalate to management.?主导相关部门进行风险评估，评估风险是否受影响，并做必要的更新Lead the relevant departments to perform the risk assessment, and to evaluate if risk assessment is impacted, and determine the needs of updating risk assessment file.?在Catsweb系统完成投诉调查总结及整个投诉文档的最终报告。Complete investigation request summary, and final summary of the complaint folder in Catsweb.?管理投诉相关的退回样和留样。Manage complaint related returned sample and retained sample.?支持杭州工厂的投诉CIE项目。Support CIE project in Hangzhou site.?在SAP系统查询、追踪产品、物料信息。Trace back product and material information in SAP.2.不符合事件处理Nonconformance Handling : 15%?协调不符合事件的发起、影响范围、围堵措施和影响评估。Coordinating the initiation, bracketing and containment determination, and impact assessment.?协调不符合基础事件报告的批准和产品/物料处置。Coordinating the approval of base ER and product/material disposition.?确定产品在各阶段处置已经完成，并评估相关更正措施的有效性。Confirm the product containment at all level of product movement, and evaluate the effectiveness of correction with regard to product.?对于发生在生产部、工程部、仓库等区域的一些重大质量问题，如有需要一起进行调查，找出原因和必要时提出纠正措施计划。Participate in the investigation for major quality issue in production area, facilities department and warehouse as required, identify the root cause and recommend the corrective action plan if necessary.?制定有效取样计划帮助调查和产品评估。Establish the valid acceptance sampling plan to facilitate the investigation and product impact assessment.?运用质量统计技术对质量数据进行数据分析，向管理层汇报趋势并必要时提出预防措施计划。Conduct the data analysis by quality tool, and report the trending to the plant management and recommend the preventive action plan if necessary.3.风险管理Risk Management：15%?维护杭州工厂的风险管理系统，包括差距分析、更新风险评估程序、过程/设计FMEA等。Maintain Risk Management System of AMO Hangzhou, including gap analysis, Risk Assessment procedure update, process/design FMEA update, etc.?作为风险管理话题专家，参与、指导杭州工厂发生的的不符合的影响评估。As the SME of risk management in AMO Hangzhou, participating and guiding impact assessment for Non-conformance occurred in AMO Hangzhou.4.产品质量回顾Product Quality Review : 15%?负责协调年度产品质量数据收集、分析和回顾。Responsible for coordinating the annual product quality data collection, analysis and review.?负责协调、起草产品质量回顾报告，确保按时完成。Responsible for coordinating and drafting product quality report to enable the completion on time.5.审计支持和项目管理 Audit Assisting and Project Management : 10%?参与审计准备和完成审计分配的任务。Participate in the audit preparation and assigned works are completed in timely manner.?支持相关部门的项目。Assist in development of special department projects.?确保项目按计划完成并达成预期结果。Accountable for project completions and achievement of compliance goals.?与项目团队和跨部门团队讨论与质量运营范畴内的事宜。Interact with Project Teams and cross-functional groups as they impact the quality operation6.其他: Others: 10%?维护和报告部门质量数据和趋势报告。Maintain and report applicable department or organizational metrics and trend reports.?质量运行经理指定的其它工作。Complete the temporary tasks assigned by Operation Quality Manager.学历和经验EDUCATION ADN EXPERIENCE本科学历，至少3年制药/医疗器械产品行业QA部门工作经验，有无菌生产经验者佳。BS and min. 3 years working experience in quality management of pharmaceutical/medical device industry, and sterile production experience is preferred.必备技能: ESSENTIAL SKILLS AND ABILITIES:1.GMP工作经验和ICH Q8, Q9, Q10, ISO13485和其他国际法规要求。Experience working in a GMP environment and knowledge of ICH Q8, Q9, Q10, ISO13485 and other international regulatory requirements.2.熟练运用质量工具(Minitab, Cpk)进行数据统计和分析。Familiar with quality tools (like Minitab, Cpk) to perform data stat. and analysis.3.熟练运用风险评估工具（失效模式和影响分析，工艺危害性分析等）。Familiar with risk assessment tools (FMEA, PHA, etc.)4.良好的英语沟通能力Command English well5.最好有CQA 证书，如果有CQE,CQM或其他ASQ证书更佳。Certification in CQA is preferred, CQE, CQM, and/or member of ASQ is desired. 职能类别： 药品生产/质量管理 医疗器械生产/质量管理

联系方式

杭州市经济技术开发区四号大街

公司信息

雅培眼力健 世界护眼专家 雅培眼力健（杭州）制药有限公司 雅培眼力健为美国医药巨头雅培公司的医疗光学事业部，是一家从事专业化医疗保健及护眼产品研发、生产和销售的国际性公司，在护眼产品及眼科医疗手术器械方面都具有世界领先地位。雅培公司总部设在美国芝加哥，眼力健美国公司位于加州圣安娜市，其子公司、分部及代理商遍布世界各地。 占地七万余平米的雅培眼力健(杭州)制药有限公司，是雅培眼力健独家投资近三千万美元建造的生产护眼系列产品的公司。公司产品大部分出口到日本、美国、欧洲及亚太其他国家和地区。公司的产品以其特有的品质倍受中高收入群体的青睐，其中全能品牌作为总公司隐形眼镜护理液的主打品牌，全球年销售额呈不断攀升的势头。为满足日益增长的全球市场需求,公司规模不断扩大,生产能力不断提高，现特此诚征专业技术及管理英才。 公司将为您提供具有竞争力的薪酬水平,完善的养老保险、失业保险、工伤保险；住房公积金制度；医疗保障制度 （高比例报销医疗费、住院保险、子女医药费部分报销制度）；意外伤害保险和寿险； 年度薪资增长计划；带薪休假制度；跟绩效管理体系相挂钩的奖金制度;晋升制度和内部应聘转岗制度;长期贡献奖;完整的培训体系 有意者在一周内请将中英文简历、身份证及学历证书复印件寄至：杭州经济技术开发区4号200号大街雅培眼力健（杭州）制药有限公司人力资源部收，邮编310018，或E-Mail: hz_recruit@amo.abbott.com，合则约见，谢绝来电来访。

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