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
61 发放批生产记录
61 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
61 制止生产中的偏差，并督促改进
61 审核批生产记录和分析原始记录
61 负责对成品、半成品及留样的抽样
61 发放产品和半成品的合格标签
生产区域的环境监控
61 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
61 按照SOP的规定，定期监测压缩空气系统的微生物
61 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
61 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
61 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
61 参与验证所需的取样
61 执行上级指派的其他与质量管理相关的工作

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

4. 能力要求/Competence
61 具有药学或相关专业大专及以上学历；
61 3-5年医药行业工作经验，有QA工作经验者优先；
61 熟练使用电脑办公软件。

61 Should have a pharmaceutical or related college degree or above；
61 3-5 years working experience in pharmaceutical industry，QA working experience is a plus；
61 Good skills at using office software.

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