负责安排,计划进料,成品检验,审核数据。参与不合格品调查,处理。与供应商沟通,处理物料的质量问题。起草有关检验文件。培训检验人员。负责质量文化的推广及总部的各项质量活动并定期汇报,包括但不限于BBQ,GMP评估,质量周等,并协调、主导质量改善项目推进。 完成QA经理交给工作任务。
Participate in management review report related work.
参与公司管理评审报告相关工作;
Involved in the supplier quality system audit plan, implementation, tracking, close related CAPA tracking.
参与相关供应商质量体系审核的计划、实施、跟踪及关闭及有关CAPA的跟踪;
Review inspection data, lead the investigation report of non-conformance data.
审核检验数据,主导不合格数据的调查,报告;
Proactively raise improvement suggestion drive continuous improvement based on product testing/monitdata analysis.
根据产品测试/监控数据分析,主动提出改进建议并推动持续改进;
Lead incoming material quality investigation make continuous improvement.
主导进料质量问题调查和持续改进;
Lead quality improvement project, support/facilitate projects including but not limited to new products introduction, CTW, sustaining etc.
主导质量改进项目,并支持/促进项目,包括但不限于新产品的引进,CTW,sustaining等项目;
Lead QNs product customer complaint investigation improvement.
主导质量异常及产品投诉的调查及改进; Establish accept transfer the measurement method fraw material inspection, in-process inspection outgoing inspection.
建立原材料,过程检验和出货检验的测试方法;
Ensure all inspection tasks can be completed accurately timely. Training inspectors ensure online inspection efficiency effectiveness continue improvement.
确保各项检验任务准确及时完成,培训检验员并保证在线检验效率及有效性持续改善;
Act as a key member of Cell team, ensure all actions meet GMP product quality requirement, assist Cell team to do process optimization. Provide supporting fproduct risk management.
作为Cell团队的主要成员,确保所有的行动满足GMP和产品质量要求,协助Cell团队实施工艺流程优化,对产品的风险管理提供支持; Responsible review fproject validation report, ensures the content meets all applicable quality system requirements product requirements.
负责项目验证报告的评审,确保内容符合所有适用的质量体系要求和产品要求;
Batch process record data review, ensure BPR meet GMP requirement product release on time.
批记录及数据审核,确保批记录满足GMP的要求并确保产品按时释放; Promote quality culture, lead report global quality initiative, include but not limit BBQ,GMP assessment, quality week etc.
负责质量文化的推广及总部的各项质量活动并定期汇报,包括但不限于BBQ,GMP评估,质量周等
QA department SAP/ECC system maintenance.
质量部门SAP/ECC系统的维护;
Coordinate lead quality improvement projects.
协调、主导质量改善项目的推进;
Coordinate lead Quality system& culture improvement
Complete other related work.
完成交付的其他相关工作;