锦鲤求职岗位描述
Responsibilities:职责：1.Responsible for routine quality oversight for DS GMP areas to ensure all GMP activities are executed based on regulations, SOPs and related procedures.负责对原液GMP生产区域进行日常质量监督，以确保所有GMP活动均根据法规、SOP和相关程序执行。2.Responsible for review and approval of DS manufacturing and testing related documents.负责原液生产和检验相关文件的审核和批准。3.Responsible for DS manufacturing batch record review, electronic data batch release and electronic data periodic review.负责原液生产批记录审核、电子数据批放行审核和电子数据定期审核。4.Responsible for DS facility, utility, equipment and instrument release.负责原液生产设施、公用设施、设备和仪器的放行。5.Deeply involved in GMP related deviation, change control, CAPA and lab investigation work. Handling quality event investigation, risk assessment, complaints, participate in the formulation and implementation supervision of process control strategy and contamination control strategy.深度参与GMP相关偏差、变更控制、纠正预防措施和实验室调查工作。处理质量事件的调查、风险评估、投诉，参与工艺控制策略和污染控制策略的制定与实施监督。6.Lead improvement activities including but not limited to MBR design, SOP optimization, and quality system continuous improvement.主导改进活动，包括但不限于主生产记录设计、标准操作规程优化和质量体系的持续改进。7.Support GMP audits and inspections; Support QA project management.支持GMP审计和检查；支持 QA 项目管理工作。8.Complete other tasks assigned by the supervisor/ team leader.完成主管/团队主管分配的其他任务。