AstraZeneca Pharmaceuticals LP Assistant QA Engineer in Taizhou, China

· 为泰州生产基地创建和维护质量管理体系文件

Creating and maintenance quality management system procedure for BM manufacturing procedure

· 质量事件的调查

Investigation of quality issues

· 偏差和CAPA的管理

Deviation and CAPA management

· 变更管理

Change control management

· 参与自检

To be involved in the self-inspection

· 审核验证/确认文件

Review qualification and validation documents.

· 审核批生产记录

Review production sheet

· 负责和生产部门一起解决生产过程中的质量问题

Responsible for solving the quality issues with operation team.

· 如经授权,负责中间产品、原辅料、包装材料放行

If authorized, take responsibility for bulk product, API, excipients and packing materials release

· 确保完成QA的部门目标

Ensure to fulfill the KPIs of QA

· 质量的持续改进

Quality continuous improvement

· 年度产品审核

Annual product review

· 产品质量投诉和退货处理

Product complaint and handling of returned goods

· OSD 生产部门,技术服务部门,供应链,工程和安全环保健康部门

OSD production, TS, Supply chain department, E&SHE

作为阿斯利康泰州供应基地的一名员工,每一位员工对其本人与他人的业务行为、健康与安全、环境保护、帮助公司持续改进绩效和声誉负有相应的责任。因此,每一位员工必须:

As an employee in Taizhou Supply Site, everyone should be responsible for health and safe、environment protection of him/herself and colleagues, assist company to continually improve the performance and reputation. According to this, every employee should:

· 理解其业务活动中涉及安全、健康及环境的相关内容以及该活动可能对整个公司的安全、健康环境绩效产生的影响。

Understand the business activities related to the content of safety、health and environment ,and the appropriate effects to the entire company’s safety, health and environment.

· 参加培训并提出必要的培训需求,确保其业务活动的安全、合法,保护环境。

Attending the training and raise necessary training requirements, ensure the safety, compliance of the business activities, and the protection of environment.

· 持续表现符合政策的安全、健康与环境行为,并通过交流与沟通,持续改善安全、健康与环境的绩效。

Continually demonstrate the behavior corresponding with policy of safety, health and environment, also continually improve the performance of safety, health and environment through interpersonal communication.

· 严格执行本岗位的安全操作规程,并按要求正确使用劳动防护用品,拒绝违章指挥,切实做到“四不伤害”,即不伤害自己,不伤害别人,不被别人伤害,保护别人不受伤害;

Stickily follow the job’s safety operation process, and use articles for labor protection correctly, refuse commanding against rules, achieve the goal of “No Hurts FOUR”, neither hurt oneself, nor hurt others, do not be hurt by others, and prevent others to be hurt;

· 可以向您的直接经理或通过行为准则帮助热线就您工作中遇到的安全、健康与环境的有关问题及建议、他人的相关表现以及公司的安全、健康环境绩效进行沟通。

You can report to your line manager or use the hotline of code of conduct to communicate with the encountered safety, health and environment issues, also company’s safety, healthy environment performance can be communicated.

· 采取积极的、正确的态度真实地、准确地填写有关安全、健康与环境绩效的记录以及相关文件,并进行汇总、提交、保存,这有利于公司对所设定目标的进展进行准确地评估,并将评估信息与相关方或其他相关人员进行分享。

Adopt the positive, right attitude to fill in related documents about safety, health and environment performance correctly, summarize, submit and save them. These activities will help to evaluated company’s goal accurately, and it will also be shared with interested parties or other related people.

· 按照GMP要求建立和完善质量管理体系 Establish and maintain quality management system based on GMP requirements

· 监督工厂GMP的有效执行 Supervise effective execution of GMP

· 为其它部门提供GMP支持、建议和培训 Provide GMP support, suggestion and training to other functions

· 关注法规的变更和评估,并与其它部门沟通 Focus on changes of regulations and impact assessment, and communicate with other functions

· 确保质量体系各模块的法规符合性Ensure regulatory compliance of quality management system