About this role
<p style="margin:0.0cm 10.5pt 0.0cm 0.0cm;text-align:justify;font-size:10.5pt;font-family:Calibri, sans-serif"><strong><span style="font-size:9.0pt;font-family:SimSun">岗位职责：</span></strong></p> <p style="line-height:15.0pt;margin:0.0cm;text-align:justify;font-size:10.5pt;font-family:Calibri, sans-serif"><span style="font-size:9.0pt;font-family:Symbol">·</span><span style="font-size:9.0pt;font-family:Arial, sans-serif"> </span><span style="font-size:9.0pt;font-family:SimSun">负责工厂系统验证流程的维护；</span></p> <p style="line-height:15.0pt;margin:0.0cm;text-align:justify;font-size:10.5pt;font-family:Calibri, sans-serif"><span style="font-size:9.0pt;font-family:Symbol">·</span><span style="font-size:9.0pt;font-family:Arial, sans-serif"> </span><span style="font-size:9.0pt;font-family:SimSun">负责制定厂房设施、公用系统和工艺设备验证计划，并确保顺利实施；</span></p> <p style="line-height:15.0pt;margin:0.0cm;text-align:justify;font-size:10.5pt;font-family:Calibri, sans-serif"><span style="font-size:9.0pt;font-family:Symbol">·</span><span style="font-size:9.0pt;font-family:Arial, sans-serif"> </span><span style="font-size:9.0pt;font-family:SimSun">负责相关厂房设施、公用系统和工艺设备验证</span><span style="font-size:9.0pt;font-family:SimSun">风险评估、验证方案和报告的编制</span><span style="font-size:9.0pt;font-family:SimSun">；</span></p> <p style="line-height:15.0pt;margin:0.0cm;text-align:justify;font-size:10.5pt;font-family:Calibri, sans-serif"><span style="font-size:9.0pt;font-family:Symbol">·</span><span style="font-size:9.0pt;font-family:Arial, sans-serif"> </span><span style="font-size:9.0pt;font-family:SimSun">审核供应商提供的验证文件；对供应商验证文件进行差距分析；</span></p> <p style="line-height:15.0pt;margin:0.0cm;text-align:justify;font-size:10.5pt;font-family:Calibri, sans-serif"><span style="font-size:9.0pt;font-family:Symbol">·</span><span style="font-size:9.0pt;font-family:Arial, sans-serif"> </span><span style="font-size:9.0pt;font-family:SimSun">负责厂房设施、公用系统和工艺设备验证</span><span style="font-size:9.0pt;font-family:SimSun">的协调和管理，参与执行验证测试</span><span style="font-size:9.0pt;font-family:SimSun">；</span></p> <p style="line-height:15.0pt;margin:0.0cm;text-align:justify;font-size:10.5pt;font-family:Calibri, sans-serif"><span style="font-size:9.0pt;font-family:Symbol">·</span><span style="font-size:9.0pt;font-family:Arial, sans-serif"> </span><span style="font-size:9.0pt;font-family:SimSun">协助处理其它设备确认的实施与管理；</span></p> <p style="line-height:15.0pt;margin:0.0cm;text-align:justify;font-size:10.5pt;font-family:Calibri, sans-serif"><span style="font-size:9.0pt;font-family:Symbol">·</span><span style="font-size:9.0pt;font-family:Arial, sans-serif"> </span><span style="font-size:9.0pt;font-family:SimSun">协助处理相关的质量事件，包括但不限于偏差、变更、</span><span style="font-size:9.0pt;font-family:Arial, sans-serif">CAPA</span><span style="font-size:9.0pt;font-family:SimSun">等。</span></p> <p style="margin:0.0cm 10.5pt 0.0cm 0.0cm;text-align:justify;font-size:10.5pt;font-family:Calibri, sans-serif"><span style="font-size:9.0pt;font-family:Symbol">·</span><span style="font-size:9.0pt;font-family:Arial, sans-serif"> </span><span style="font-size:9.0pt;font-family:SimSun">完成上级领导交付的其他工作。</span></p> <p style="margin:0.0cm 10.5pt 0.0cm 0.0cm;text-align:justify;font-size:10.5pt;font-family:Calibri, sans-serif"> </p> <p style="margin:0.0cm 10.5pt 0.0cm 0.0cm;text-align:justify;font-size:10.5pt;font-family:Calibri, sans-serif"><strong><span style="font-size:9.0pt;font-family:SimSun">任职要求：</span></strong></p> <p style="line-height:15.0pt;margin:0.0cm;text-align:justify;font-size:10.5pt;font-family:Calibri, sans-serif"><span style="font-size:9.0pt;font-family:Symbol">·</span><span style="font-size:9.0pt;font-family:Arial, sans-serif"> </span><span style="font-size:9.0pt;font-family:SimSun">本科及以上学历，生物工程、生物技术或其他制药相关专业；</span></p> <p style="line-height:15.0pt;margin:0.0cm;text-align:justify;font-size:10.5pt;font-family:Calibri, sans-serif"><span style="font-size:9.0pt;font-family:Symbol">·</span><span style="font-size:9.0pt;font-family:Arial, sans-serif"> </span><span style="font-size:9.0pt;font-family:SimSun">具备</span><span style="font-size:9.0pt;font-family:Arial, sans-serif">6</span><span style="font-size:9.0pt;font-family:SimSun">年以上制药企业验证相关工作经验，有生物制药行业经验者优先；</span></p> <p style="line-height:15.0pt;margin:0.0cm;text-align:justify;font-size:10.5pt;font-family:Calibri, sans-serif"><span style="font-size:9.0pt;font-family:Symbol">·</span><span style="font-size:9.0pt;font-family:Arial, sans-serif"> </span><span style="font-size:9.0pt;font-family:SimSun">熟悉制药行业验证体系、法规要求及相关工作流程，能够独立开展验证工作；</span></p> <p style="line-height:15.0pt;margin:0.0cm;text-align:justify;font-size:10.5pt;font-family:Calibri, sans-serif"><span style="font-size:9.0pt;font-family:Symbol">·</span><span style="font-size:9.0pt;font-family:Arial, sans-serif"> </span><span style="font-size:9.0pt;font-family:SimSun">英语达到</span><span style="font-size:9.0pt;font-family:Arial, sans-serif">CET-6</span><span style="font-size:9.0pt;font-family:SimSun">及以上水平，具备良好的英文听、说、读、写能力，可作为工作语言；</span></p> <p style="line-height:15.0pt;margin:0.0cm;text-align:justify;font-size:10.5pt;font-family:Calibri, sans-serif"><span style="font-size:9.0pt;font-family:Symbol">·</span><span style="font-size:9.0pt;font-family:Arial, sans-serif"> </span><span style="font-size:9.0pt;font-family:SimSun">责任心强，具备良好的沟通协调能力、问题分析与解决能力。</span></p> <p style="margin:0.0cm 10.5pt 0.0cm 0.0cm;text-align:justify;font-size:10.5pt;font-family:Calibri, sans-serif"> </p>