南平招聘

Expected Areas of Responsibilities 工作职责：

1. Perform the routine inspections on the key steps in production area according to the SOPs, to ensure the routine operations comply with the requirements of SOP, GMP and MLS/PLS

按SOP要求对生产区域各工段进行工作，确保日常操作符合SOP 、GMP及MLS/PLS的要求

2. Sample the intermediate bulk or finished product according to Sampling Manual, and send it to QC. Enter the sample data in LIMS system.

按取样手册要求对产品中间体/成品进行取样，并及时送样在LIMS系统中输入样品数据

3. Fully investigate the quality event to find the root cause and fulfill the investigation report. Take the proper corrective actions & preventive actions (CAPA) and follow-up the timely completion of CAPA.

对质量事件进行调查以确认事件根源，并完成调查报告采取适当的整改措施（CAPA）并跟踪 其及时完成

4. Investigate customer complaint and fulfill the investigation report. Take the proper corrective actions & preventive actions (CAPA) and follow-up the timely completion of CAPA.

对顾客抱怨进行调查，并完成调查报告采取适当的整改措施（CAPA）并跟踪其及时完成

5. Participate and monitor the validation of the manufacture process and facilities cleaning, and sample the products by the requirement of validation

参与产品生产过程及设备清洁验证，监督验证过程并按验证要求取样

6. Establish the relevant SOPs according to the requirements of cGMP and actual operations, to ensure the operations comply with SOPs.

根据GMP要求和实际日常工作情况制定相关SOP，确保操作与SOP一致

7. Control the status of the raw materials and intermediate bulks used for production. And inquire, re-check and change the status of some raw materials and packaging materials in SAP system

生产过程中物料、中间体的状态控制并在SAP系统中查 询 、核对及修改物 料 状 态

8. Perform the sampling of environment and water system in production area according to the sampling method and frequency in SOP.

按照SOP规定的操作方法及取样频率对生产区域的环境及水系统进行取样

9. Check PO and BOM to make sure the veracity

检查生产指令单及BOM以确保其准确无误

10. Complete other assignments given by the superior

完成领导交办的其它任务

Experiences Desired相关工作经验要求：

1.2 years or above work experience in quality unit of pharmaceutical company

   两年以上制药行业质量部门工作经验

2.Familiar with government regulation regarding to GMP and pharmaceutical technical process.

    熟悉GMP和制药工艺

Skills & Ability Desired 必要的技能和能力 ：

1. Ability to use MS Office

    具备使用办公室软件的能力

2. Ability of effective communication

    具备有效沟通的能力

3. Ability of logical thinking

    具备良好的逻辑思维的能力

4. Ability of problem solving

    具备解决问题的能力

百时美施贵宝是一家以“研发并提供创新药物，帮助患者战胜严重疾病”为使命的全球性生物制药公司。

2019年11月20日，百时美施贵宝成功完成了对新基的收购，将双方在领先的科学、创新的药物和优秀的人才等方面的优势合二为一，打造全球领先的生物制药企业。公司在肿瘤、血液、免疫和心血管疾病等领域处于世界前列，并具有丰富的，且具有行业前景的产品管线。

如今，中国已是百时美施贵宝公司全球重要的研发、生产、营销和创新中心之一。我们致力于满足中国未被满足的迫切的重大疾病需求，引领行业发展，开展多元合作，以帮助中国患者战胜严重疾病。