工作内容 CONTENT
1.学习国家药品法律、法规，以指导质量管理工作；Learn national drug law and regulations, in order to guide the quality management work.
2.负责物料供应商的资质审核，组织相关部门对物料供应商进行评估确认；Responsible for the qualification audit of material suppliers, organize related departments to evaluate and confirm material suppliers.
3.制定供应商年度现场审计计划；Prepare the supplier’s annual no-site audit plan.
4.组织相关部门对供应商进行现场审计，起草审计报告；Organize relevant departments to perform on-site audit of suppliers and draft audit report.
5.建立供应商档案，定期对供应商资质进行回顾；Establish supplier file and review supplier qualification regularly.
6.负责供应商投诉，供应商整改回复后，对供应商供货能力进行评定；Responsible for supplier complaints, confirm if the supplier can supply qualified materials after the supplier's rectification reply.
7.维护合格供应商清单及取消资格的供应商清单，负责清单的起草、发放、回收、销毁、归档等；Maintain the list of qualified suppliers and the list of disqualified suppliers. Responsible for drafting, distribution, recycling, destruction and filing of lists.
8.对供应商供货质量情况进行年度回顾；Conduct annual review of supplier quality.
9.负责物料及易耗品检测报告的审核及放行工作，发放合格标签；Responsible for review material and consumable test report and release work, the distribution of released label.
10.批准特殊物料申请，并维护特殊物料单；负责清单的起草、发放、回收、销毁、归档等；Approve special material request and maintain special material list. Responsible for drafting, distribution, recycling, destruction and filing of lists.
11.不合格品管理；Management of nonconforming product.
12.负责易耗品供应商、服务商、运输代理商的资质审核，组织相关部门对供应商进行评估确认。维护供应商清单；Responsible for the qualification audit of consumable suppliers, service suppliers and transportation suppliers, and organize related departments to evaluate and confirm the suppliers. Maintenance supplier list.
13.组织相关部门对服务商进行年度回顾；Organize relevant departments to conduct an annual review of service suppliers.
14.仓库现场日常巡查及管理工作，审核EMS报告；Daily inspection and management of warehouse, review the report of EMS.
15.参与相关SOP起草、修订和审核；Drafting/update/review of related SOP.
16.协助库房现场、物料及供应商相关的变更、偏差，CAPA管理; Assist in the management of change control, deviations, CAPA of Warehouse，material and supplier.
17参与QMS系统的项目实施以及日常管理；Participate in the project implementation and daily management of QMS system.
18.协助外部审计的准备、迎审工作。Assist in preparing and welcoming external audit.
19.领导交代的其他事宜。Complete other tasks assigned by superior leaders.
教育背景和任职资格EDUCATION BACKGROUND AND QUALIFICATION
1.具有化学、制药及相关专业专科及以上学历，优秀人员可适当放宽条件，包括工作经验。College degree or above in chemistry or pharmaceutical or related majors. excellent personnel requirement can be appropriately relaxed to include work experience.
2.有1年以上相关工作经验。Have 1 year or above work experience.
3.熟悉原料药相关GMP法规。Familiar with GMP and relevant regulations about API.
4.具有很强的团队协作意识和沟通技巧。Have strong sense of teamwork and communication skills.
5.具有较强的任务执行能力。Have strong ability of task execution.