锦鲤求职岗位描述
1. 负责生产所用物料（原辅料，关键性生产耗材，包装材料）的供应商（生产商和经销商）的管理，包括但不限于供应商的资格审查，评估，现场审计，定期评估等一系列管理活动。Responsible of management of all suppliers (manufacturer and distributor) of materials (raw materials ,excipients key consumables and packing components), including but not limited to qualification ,evaluation ,on site audit and periodical assessment. 2. 负责外包服务商（包括但不限于外包测试，计量，审计，验证，运输等）的管理，包括但不限于外包服务商的资格审查，评估，现场审计，定期评估等一系列管理活动。 Responsible of management of contracted service providers (material testing ,calibration ,audit validation and transportation etc.) including but m=not limited to qualification ,evaluation, on site audit and periodical assessment. 3. 负责供应商清单，外包服务商清单的更新和维护，确保所有的GMP物料供应商和GMP活动服务商是经过批准的。 Responsible of updating and maintaining of approved supplier list and approved contracted service provider list ,make sure that all suppliers of GMP materials and service providers of GMP activities are qualified. 4. 负责相关QSG和SOP的起草和修订。 Responsible of drafting or updating of relative QSG or SOP. 5. 负责物料代码的审核和批准。 Responsible of reviewing and approving of material code. 6. 负责供应商变更通知的评估。Responsible for the assessment of supplier change notifications. 7. 起草、审核与供应商的质量保证协议。Creating or reviewing the quality agreement between WuXi Bio and supplier. 8. 完成直接主管安排的临时任务。Complete the temporary tasks assigned by supervisor.
岗位要求：
大学本科及以上；生物学/药学/化学/微生物学等相关专业；熟悉FDA,EMA,NMPA等相关法规
Bachelor or above; Biology/Pharmaceutical/Chemistry/Microbiology; Be familiar with the regulation of FDA, EMA and NMPA
良好的英语读写能力，基本听书能力；熟练使用计算机办公软件（Word, Excel, Power Point）和邮件收发；具有较强的组织，沟通、团队合作，高效执行，独立工作能力
Good reading & writing of English, basic listening& speaking skill of English; Use office software (Word, Excel, Power Point) and OUTLOOK in proficiency; Strong capability of organizing, communicating, team working, executing independently