锦鲤求职岗位描述
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.