1. Be accountable for the environment ,hygiene safety and quality issues in position as well as subordinates (if available)
对本岗位职责范围内的环境卫生安全和质量负责，并对下属(如果有)的工作质量和环境安全负有责任。
2. Maintain and implement the best, surest and easiest work processes. Initiate, participate and facilitate the continuous improvement activities on safety, quality, cost, delivery, motivation and environment by applying DaMaWay (including LEAN principles etc).
维护并实施***、最可靠、最简单的工作流程；应用DaMaWay (包括精益原理等)，在安全、质量、成本、交付、激励和环境方面,发起、参与并推动持续改进活动。
3. Ensure the quality compliance of process.
确保生产过程的质量符合性
--Sampling and monitoring for subassembly, on-line products and finished products.
中间产品，待包装产品，成品的取样及监控
--Check the post clearance, including equipment and site, and make an approval.
对岗位清场工作（包括设备，场所）进行检查，并签发合格证。
-- Be responsible for primary handing of production deviation and recording
负责生产过程中异常情况的处理和记录
-- Be responsible for bulk product releasing in production
负责生产过程中间产品、待包装产品的放行
4. Follow up control control and deviation on site execution跟踪变更和验证现场实施
Follow up the validation action, make sure the legal and product quality complance. 对现场的验证进行跟踪，确认验证的法规和产品质量符合性
Train the quality operation, arrsure the quliaty when control on site. 把变更涉及的质量操作培训到生产现场并进行持续跟踪，确认变更在实施过程中的质量符合性
5. Retention sample and stability retention sample留样和稳定性留样
Make a sample retention plan, observe the characters every month, send them for inspection in time, and analyze the trend of the results制定留样计划，每月观察性状，及时送检，对结果进行趋势分析
6. Evaluation and update of intermediate quality control质量中间控制的评估和更新
Regularly evaluate process control and adjust the items and frequency of process control定期对过程控制进行评估，调整过程控制的项目和频次
7. Track and review the water quality of ECN process and the environmental quality of Class D area annually to ensure that the production needs of GMP are met对ECN工艺用水质量、D级区环境质量进行跟踪与年度回顾，确保满足GMP的生产需要
8. BPR review 批记录审阅
Be responsible for the conformity of BPR负责批记录的符合性。
9. BPR management 批记录管理
Be responsible for archiving, borrowing and destroyed of BPR负责批记录的存档，借阅，销毁负责生产过程中异常情况的处理和记录
-- Be responsible for bulk product releasing in production
负责生产过程中间产品、待包装产品的放行
10. Be responsible for product rework, return of goods and disposal of unqualified products
负责产品的返工，退货及不合格销毁处理
11. Other duties disposed by Dept. head.
上级安排的其它工作
Job Qualification: 任职资格
Education & working experience 学历与工作经验要求：
1. College or above,, with majored in scientific or technical.
大专或以上学历，工程类专业或科学技术专业
2. 3+ years of the quality management experience ( be familiar with ISO9001,GMP), be familiar with the regulation of the medical device
3年以上的质量管理经验（熟悉ISO9001,GMP）,了解药品生产的法律法规
Occupational qualifications职业资格要求：
1. Quick understand abilities and quality minded.
快速反应能力，质量意识
2. Good personnel health habit.
良好的个人卫生习惯
3. Basic English communication skill (written and verbal)
基本的英语听、说、读、写能力
4. Basic MS office skills
能够基本使用办公软件
Others其他：
Easy communication, good team player. Interaction with different types of personalities.
良好的沟通能力和团队合作精神。 能与不同性格的人打交道。
Accept working in shifts
适应倒班