1. 隶属部门/Situation in structure
属质量保证部/质量保证经理直接领导
Directly lead by QA Manager

2. 职责/Mission
负责QA部门 生产现场生产监管相关工作。
Responsible for QA Production Site Supervision related work.

3. 主要工作/Main Activities
生产现场监控
* 发放批生产记录
* 监督生产现场活动，确保每一步都遵循相应的制造工艺和SOP
* 制止生产中的偏差，并督促改进
* 审核批生产记录和分析原始记录
* 负责对成品、半成品及留样的抽样
* 发放产品和半成品的合格标签
生产区域的环境监控
* 按照SOP的规定，定期监测相关区域的悬浮粒子、浮游菌和沉降菌
* 按照SOP的规定，定期监测压缩空气系统的微生物
* 每年对环境监控数据进行趋势分析
管理和跟进偏差、变更和CAPA
* 根据SOP的规定，管理和跟进偏差、变更控制和纠正与预防措施（CAPA）
参与质保部开展的质量活动
* 参与质保部的日常工作，包括不合格证的发放、物料合格证的发放、包材的检查等
* 参与验证所需的取样
* 执行上级指派的其他与质量管理相关的工作

Production Site Supervision
* Issuance of batch manufacturing records
* Supervise the activities in the site of production, check if every step follows the corresponding manufacturing process and related SOP
* Prevent deviations in production, urge the improvement
* Check the batch records of production and analyses
* Take samples of finished products, semi-finished products, and reserved samples
* Issuance of approved labels for finished products and semi-finished products
Environment Monitoring of Production Area
* According to specified SOPs, periodically monitor the air-borne particles, air-borne microbe, and settling microbe in related areas
* According to specified SOP, periodically monitor the microbe of the compressed air system
* Perform annual trend analysis on environment monitoring data
Management and Follow-up of Deviations, Change Control, and CAPA
* According to specified SOPs, manage and follow-up the deviations, change control, and CAPA
Participation in Quality Assurance Department Activities
* Participate in the daily work of the Quality Assurance department: issuance of rejected labels and material approved labels; check of packaging materials etc.
* Participate in the sampling required for validation
* Other works related to quality management appointed by superior

4. 能力要求/Competence
* 具有药学或相关专业大专及以上学历；
* 3-5年医药行业工作经验，有QA工作经验者优先；
* 熟练使用电脑办公软件。

* Should have a pharmaceutical or related college degree or above；
* 3-5 years working experience in pharmaceutical industry，QA working experience is a plus；
* Good skills at using office software.

5. 个性要求/ personality requirement
* 性格积极向上，富于团队精神。
* Positive attitude，team work spirit.