QA Technician 技术员

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.