1. Quality assurance oversight for all QC Lab GMP activities:
质量保证和监督所有QC实验室GMP活动。
a.Review GMP documents and records from QC department according to existing procedures.
应根据现有规程，对QC部门的GMP文件和记录进行审核。
b. On-site supervision of the QC Lab area to ensure that the experimental process and verification process are carried out in accordance with the established procedures, Take the necessary measures against existing or potential quality risks
对QC实验室进行现场监督，确保实验过程、验证过程按照既定的规程进行，对已有或潜在的质量风险采取必要的措施。
c.Regularly review the findings in the quality oversight process
对质量监督过程中的发现项定期进行回顾。
d. Report and participate in the investigation of all quality-related incidents involved in a timely manner, such as: deviation changes, CAPA, OOX (out-of-limit results, out-of-expected results, out-of-trend results, etc.).
对涉及的所有与质量相关的事件及时汇报并参与调查，例如：偏差变更、CAPA、OOX（超限的结果，超预期的结果，超趋势的结果等）。
e. Release放行:
1) Review inspection and related documents and records to ensure compliance with GMP, registration requirements and quality standards.
审核检验及报告等相关文件及记录 ，确保符合GMP、注册要求和质量标准。
2) Review the batch release file to ensure that the corresponding issues have been resolved or closed before the release of the finished product.
对批放行档案进行审核，确保成品放行前相应的问题已得到解决或关闭。
3) Review the material release file.
对物料放行档案进行审核。
f.Audit: ensure inspection readiness of the site with respect to all internal and external audits within and external to the company. When required provide responses and timely follow up on relevant corrective actions and commitments as a result of the inspections.
审计：确保所有公司内部和外部审计的现场检查准备就绪。如有需要时，对检查结果的相关纠正措施和承诺，作出回应并及时跟进。
g.Key QMS elements implementation: include but not limited to:
质量管理体系关键要素实施:包括但不限于：
1)Maintain GMP documentation in compliance manner, identifying trends to prevent recurrence, assure proper corrective actions are assigned and completed and appropriate notification is made to all relevant parties
在合规的方式下，维护管理GMP文件，识别趋势以防止再次发生，确保适当的纠正措施被分配和完成，并向所有相关方发出适当的通知;
2) Implement QRM where applicable
适用时实施QRM
2. Accountable for the execution of the work assigned by superior, ensure effective and efficient way of working
负责执行上级布置的工作，确保高效的工作方式。
a. Involved in coaching program
参与培训计划
b. Optimize the work arrangement continuously for high efficiency
不断优化工作安排，提高工作效率
2. Accountable for the execution of the work assigned by superior, ensure effective and efficient way of working
负责执行上级布置的工作，确保高效的工作方式。
a. Involved in coaching program
参与培训计划
b. Optimize the work arrangement continuously for high efficiency
不断优化工作安排，提高工作效率
c.Ability to learn independenty.
有自主学习的能力
3.Collect and archive data according to the project.
根据项目进行交付资料的整理、归档。
1.Strong expertise in QMS and HA inspections, comprehensive knowledge
在质量管理体系和HA检查方面，具有较强的专业知识;
2.Practical experience in QA owned processes such as Deviation, CC, batch disposition etc...
具有QA相关流程的实际经验，如偏差、变更、批处置等。
3.This position requires the individual to be able to
岗位任职要求：
a)handle multi-tasks and provide leadership to implement solutions to complex problems using the best available technology,
处理多项任务，并通过使用***可用方法，领导和提供解决复杂问题的方案;
b)assess impact and make decisions and take accountability
评估影响，做出决定并承担责任；
c).demonstrate the active skill in challenging status quo, offering practical alternatives
具备主动挑战现状的技能，提供切实可行的替代方案；
d).demonstrate the ability to develop and promote an environment that nurture creativity and improvement of the current way of working.
具备营造和促进能培养创造力、改进当前工作方式的环境的能力；
e).Have good understanding on manufacturing processes and unit operation.
对生产工艺和单元操作有充分的了解。
f).Lead by example, Strong communication skills
以身作则,较强的沟通能力
Bachelor Degree or above
学士及以上学位
Pharmacy, Chemistry, Biochemistry and equivalent is prefer
药学、化学、生物化学及相关学科优先