SMQC testing team lead 小分子QC检测团队负责人当面告知
无锡药明合联生物技术有限公司
2027-01-21 18:05:34
其他社招
岗位详情
地区:
无锡市
专业要求:
化学药学药物分析分析化学
岗位职责:
1.作为小分子QC testing lead负责小分子QC检测团队相关工作,包括:Serving as the SMQC Testing lead, responsible for Small Molecule QC testing team activities including:-QC实验室的管理Management of QC Laboratories-指导产品相关检测方法的建立及验证及取样/检测计划,放行及稳定性方案,质量标准的制定及审批Guide the establishment and validation of product-related test methods and sampling/testing plans, release and stability protocols, and the establishment and approval of specifications-指导原辅料检测方法建立及验证,质量标准的制定及审批,取样及检测管理Guide the establishment and validation of testing methods for raw materials and excipients, establishment and approval of quality specifications. Manage the sampling and testing workflow.-QC项目相关工作管理及客户关系维护 QC Project management and customer relationship maintenance2.协助小分子QC部门负责人持续改进GMP质量管理水平及提升工作效率Support SMQC Head in continuous improvement of GMP quality management level and work efficiency-本部门及相关部门GMP文件的审批,如SOP、风险评估报告、验证文件、方案报告等Review and approval of GMP documents including other relevant department documents , such as SOP, risk assessment, validation document and protocol report, etc.-偏差,变更,实验室调查的审批 Review and approval of Deviations, CC, and laboratory investigations-领导客户及药监部门的审计准备及问题回复Lead the audit preparation of customers and regulatory authorities and reply questions and findings-推动部门内及跨部门工作流程优化及效率提升Promote process optimization and efficiency improvement within and across departments3.参与小分子QC的日常运营,预算及成本管理Support for daily operation, budget and cost management of Small Molecule QC team-参与制定年度部门预算Participate in the development of annual departmental budget-确保小分子QC testing team下属员工所有相关人员都已经过必要的上岗前培训和继续培训Ensure that all people in Small Molecule QC testing team have received necessary pre-induction and continuing training-确保QC各项检测工作按照SOP和对应程序及时完成Ensure that all QC tests are completed in time according to SOP and corresponding procedures4.确保基地小分子QC testing team安全、合规Ensure safety and compliance of Small Molecule QC testing team-实验室安全管理Laboratory safety management-公司其他合规培训管理Corporate other compliance training management5.绩效管理、骨干培养及人才梯队建设Performance management, talent training and team building-参与制定部门KPI,并领导团队达成绩效目标Participate in the development of departmental KPI and lead team towards performance goals-人员管理,培养人员梯队,推动人才发展Team building and management, promote talent development6.完成小分子QC head安排的其他工作 Completing other work assigned by SMQC head.
招聘要求:
1.作为小分子QC testing lead负责小分子QC检测团队相关工作,包括:Serving as the SMQC Testing lead, responsible for Small Molecule QC testing team activities including:-QC实验室的管理Management of QC Laboratories-指导产品相关检测方法的建立及验证及取样/检测计划,放行及稳定性方案,质量标准的制定及审批Guide the establishment and validation of product-related test methods and sampling/testing plans, release and stability protocols, and the establishment and approval of specifications-指导原辅料检测方法建立及验证,质量标准的制定及审批,取样及检测管理Guide the establishment and validation of testing methods for raw materials and excipients, establishment and approval of quality specifications. Manage the sampling and testing workflow.-QC项目相关工作管理及客户关系维护 QC Project management and customer relationship maintenance2.协助小分子QC部门负责人持续改进GMP质量管理水平及提升工作效率Support SMQC Head in continuous improvement of GMP quality management level and work efficiency-本部门及相关部门GMP文件的审批,如SOP、风险评估报告、验证文件、方案报告等Review and approval of GMP documents including other relevant department documents , such as SOP, risk assessment, validation document and protocol report, etc.-偏差,变更,实验室调查的审批 Review and approval of Deviations, CC, and laboratory investigations-领导客户及药监部门的审计准备及问题回复Lead the audit preparation of customers and regulatory authorities and reply questions and findings-推动部门内及跨部门工作流程优化及效率提升Promote process optimization and efficiency improvement within and across departments3.参与小分子QC的日常运营,预算及成本管理Support for daily operation, budget and cost management of Small Molecule QC team-参与制定年度部门预算Participate in the development of annual departmental budget-确保小分子QC testing team下属员工所有相关人员都已经过必要的上岗前培训和继续培训Ensure that all people in Small Molecule QC testing team have received necessary pre-induction and continuing training-确保QC各项检测工作按照SOP和对应程序及时完成Ensure that all QC tests are completed in time according to SOP and corresponding procedures4.确保基地小分子QC testing team安全、合规Ensure safety and compliance of Small Molecule QC testing team-实验室安全管理Laboratory safety management-公司其他合规培训管理Corporate other compliance training management5.绩效管理、骨干培养及人才梯队建设Performance management, talent training and team building-参与制定部门KPI,并领导团队达成绩效目标Participate in the development of departmental KPI and lead team towards performance goals-人员管理,培养人员梯队,推动人才发展Team building and management, promote talent development6.完成小分子QC head安排的其他工作 Completing other work assigned by SMQC head.
公司介绍
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无锡药明合联生物技术有限公司
无锡药明合联生物技术有限公司,位于江苏,法定代表人:LI JINCAI,登记状态:存续,注册资本30000万美元,公司类型:港澳台资