成都MQA Leader

Job Responsibility

1. 01

   负责生产QA、物料/产品放行QA、QA for QC、仓库QA小组管理； Be responsible for manufacturing QA, product and material release QA, QA for QC, warehouse QA group management;

2. 02

   负责细胞库、DS生产、DP生产现场检查，确保所定的各项操作规程、批记录得到有效执行； Responsible for cell banking, DS and DP manufacturing area inspection, to ensure efficiently implement of all procedures and BPRs.

3. 03

   负责库房的监督检查，确保库房的管理符合要求； Responsible for supervising warehouse, to ensure the warehouse management meet

.

4. 04

   负责细胞库、DS、DP、QC、仓库部门相关GMP文件的审核和批准； Responsible for review and approve the GMP documents from CB, DS, DP, QC and warehouse.

5. 05

   定期或按批次审核细胞库、DS、DP区域EMS数据及其他电子数据； Review CB, DS, DP area EMS data and other electrical data periodically or according to batch production.

6. 06

   负责QC实验室数据及其电子数据审核；负责实验室日常质量监管； Review QC lab data and other electrical data periodically or according to batch testing record. Responsible for quality oversight of QC lab.

7. 07

   负责审核和协调生产、库房、QC相关的偏差、实验室调查、变更、CAPA等质量文件； Responsible for reviewing and coordinating manufacturing, warehouse and QC related Deviation, LIR, Change control, CAPA, etc.

8. 08

   负责洗衣房区域质量管理工作，包括但不限于GMP文件审核批准及现场检查； Responsible for quality management in the laundry room area, including but not limited to GMP document review and approval, as well as on-site inspections.

9. 09

   负责自建产品包括 GMP CB、 DS和 DP的放行审核。 Be responsible for product release review, including GMP CB, DS, DP.

10. 10

    协助GMP基础知识的培训，提供新工厂员工的GMP的理念、意识和水平； Assistant GMP basic knowledge training, provide the GMP concept, consciousness and standard for new plant operators.

11. 11

    完成直属领导交办的其它工作； Complete other jobs received from line manager. 教育程度/经验： Education/Experiences

12. 01

    本科及以上学历； Bachelor degree or above.

13. 02

    10年以上生物药、疫苗、基因治疗、细胞治疗或制剂生产管理或质量管理的经验； Over 10 years experience in biological medicine, vaccine, gene therapy, cell therapy or filling product management or quality management.

14. 03

    有良好的沟通技巧、工作认真、细致，具有良好的团队合作精神； Good communication, work carefully and meticulously, good team spirit. 技能要求： Skills

15. 01

    精通生物制品工艺流程，包括DS和DP； Proficient in production process of biological product, both DS and DP.

16. 02

    熟悉生物制品公用设施、公用系统、仪器设备和计算机系统，熟悉运输验证、清洁验证、检测方法验证； Expertise for the facility, utility, equipment and instrument and computerized system, be familiar with shipping validation, cleaning validation, test method validation.

17. 03

    熟悉无菌生产工艺、ORABS/隔离器、不锈钢生物反应器/发酵罐、AKTA、UFDF、灌装机（西林瓶和卡式瓶）、冻干机、自动灯检机等关键设备。 Familiar with key equipment such as ORABS/isolators, stainless steel bioreactors/fermentation tank, AKTA, UFDF, filling line (vial and cartridge), freeze dryers, and automatic visual inspection machines.

18. 04

    熟悉数据完整性监管法规； Expertise for the Data integrity governance.

19. 05

    良好的英语听说读写能力，熟练的使用计算机办公软件； Well verse in spoken and written English, skillful in using computer software.

20. 06

    有较强的分析问题、组织能力及良好的沟通技巧，工作认真、细致，具有良好的团队合作精神。 Excellent communication, problem-solving, and organization skills, attentive, careful and meticulous, with strong team-work ability. 汇报对象： 基地QA负责人 Report to: Site QA Head 下属团队： QA工程师、QA专员 Subordinate Team: QA Engineers, QA Specialists