Responsibilities:

1.质量体系管理方面

Quality systems management

- 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 Taizhou supply site

- 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

2.审核验证/确认文件

Review qualification and validation documents

3.审核批生产记录，负责和生产部门一起解决生产过程中的质量问题

Review production sheet, and responsible for solving the quality issues with operation team

4.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

5.处理QA有关的日常事务：确保完成QA的部门目标、质量的持续改进、年度产品审核、产品质量投诉和退货处理、负责创建稳定性测试方案和报告

Management of QA affairs: ensure to fulfill the KPIs of QA, quality continuous improvement, annual product review, product complaint and handling of returned goods, responsible for creating stability test protocol and report.

6.具备安全环境健康责任，达成SHE的有关事项和绩效

Possess SHE responsibilities, and fulfill SHE issues and performance

任职要求：

Requirements:

1.大学毕业，药学或相关学科

University graduate, major in pharmaceutical or related subjects

2.良好的GMP和质量体系管理知识和药学知识

Good GMP and quality system management knowledge, and pharmaceutical knowledge

3.熟悉药品法规和符合性要求，并能运用在实际工作中

Working knowledge of regulatory agency interactions and compliance procedures, with ability to apply the knowledge in an operations environment

4.熟悉过程能力控制及相关方法学知识，例如 Cpk, FMEA工具

Knowledge of Process control & capability methodology, for example Cpk, FMEA

5.具有一定的决定和问题解决能力

Knowledge of judgment and problem solving

6.医药工业5年以上质量保证工作经验。

5 years plus experience as quality assurance roles in the Pharmaceutical Industry

7.书面英语水平良好

Good written English

8.电脑使用熟练，熟悉Microsoft软件操作、SAP或相似系统的操作

Good Computer skill, and working knowledge of Microsoft applications, SAP or similar system

9.良好的沟通技巧，主动的领导意识，强烈的质量观念和服务意识

Good communication skills, proactive leadership, strong quality minds and strong service minds

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.