泰州招聘

工作职责：

Responsibilities:

1.承诺就有关符合性和质量问题提供QA的专业支持。

To commit the professional QA support in BM supply point regarding compliance and quality issues.

2.保证OSD QA完成对质量相关活动、直接影响的设备/设施相关文件的审核和批准，包括：变更申请、CAPA、偏差和产品投诉发起的质量调查、验证方案和验证报告、产品处置、标准操作规程。

Ensure OSD QA review and approval of GMP documentation that has direct impact on the activities, equipment and facilities. This includes: Change requests, CAPA, Quality investigations arising from deviations and product complaints, Validation plans, protocols and reports, Product disposition, SOP.

3.在新项目的发起、执行、结束阶段保证项目的GMP的符合性，并提供相关支持。

Ensure GMP compliance during the planning, execution and closeout phases of capital and non-capital improvement projects that support related activity.

4.审核批生产记录和放行产品。

Review production sheet and release product.

5.领导处理OSD QA有关的日常事务：质量的持续改进、退货的处理、取样留样管理、稳定性管理、投诉管理、年度产品审核。

Lead the management of OSD QA affairs: Quality continuous improvement, Returned goods handling, Sampling and retained sample management, Stability management, Complaint management, Annual product review.

6.负责OSD QA团队的日常管理。

Responsible for OSD QA team daily management.

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.全面的GMP、质量体系管理知识，和药品生产/包装技术知识。

Comprehensive knowledge of international GMP requirements, quality systems, and pharmaceutical manufacturing/packaging technologies.

3.熟悉药品法规和符合性要求，并能运用在实际工作中。

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

4.良好的精益生产理念，和相关应用工具知识。

Comprehensive understanding of Lean concepts & applications.

5.熟悉新产品引入流程。

Familiar with new product introduction process.

6.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.

7.应对产品放行时间压力的能力，保证放行到客户的产品满足所有的质量要求。

Ability to effectively balance and manage the challenges created by accelerated finished product delivery schedules and the need to ensure all quality requirements are addressed prior to the release of the finished product to AZ customers.

8.医药工业10年以上QA工作经验，5年以上主管经验。

Ten years plus experience within QA in the Pharmaceutical Industry, with at least 5 years supervisory/managerial roles.

9.英语水平良好。Good English.

10.电脑使用熟练。Good Computer skill.

11.熟悉Microsoft软件操作、SAP或相似系统的操作。

Working knowledge of Microsoft applications, SAP or similar system.

阿斯利康1993年进入中国市场。20多年来，我们不断吸引人才，通过科研创新以及卓越的执行力，真正改变患者的生活，以不断满足中国的医疗需求。中国是阿斯利康最重要的市场之一，也是我们的增长引擎。我们致力于对中国市场的长期投入。阿斯利康中国积极履行社会责任，通过与利益相关者的密切合作，以及支持身边社区的可持续发展，为中国实现构建和谐社会的目标贡献力量。

我们的愿景——开拓创新，造福病患，成为中国最值得信赖的医疗合作伙伴。

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