Senior Specialist Quality Assurance

Typical Accountabilities

主要职责

Definition of Responsibilities

职责界定

Understand/interpretation of principal to drive improvement of process

理解/解释相应的原则以推动过程改进

Issue/risk identified

问题/风险识别

Solve the problem and drive the improvement across function

解决问题并推动跨职能部门改进

Make quality decision - Quality review, approval, release

做出质量决定-质量审核，批准，放行

BPC (Business process champion) role

业务流程负责人角色

SME(Subject Matter Expert)

特定领域专家

Team management

团队管理

Coach and mentor

培训及指导

Management of QA affairs

QA 日常业务的处理

1. Shop Floor quality management

生产一线质量管理

Identify the quality risk during daily work, improve continuously.

识别日常工作中的质量风险点，持续改善

Critical shop floor issue handling and decision

生产一线严重事件的现场处理及决策

2. Quality issues handling

质量事件处理

Qualified investigator to lead Major/Critical quality issue handling, investigation and assessment

作为有资质的调查员，主导重大/严重质量事件的处理，调查和评估

Minor deviation approval

负责微小偏差的批准

3. Material release (following completion of training and authorization)

物料放行（经培训、上岗授权后）

4. Business support and continuous improvement

业务支持及持续改善

Support PET business processes regarding compliance and quality

就法规符合性和质量给予PET 业务支持

Drive continuous improvement in cross function

推动跨部门的持续改善

Lead team project/support cross team project

负责团队项目/支持跨团队项目

5. Inspections and audit

自检及审计

To be involved in regulatory inspections and self-inspection

参与审计和自检

Act as coordinator in regulatory or global audit if needed.

在审计过程中担当协调员(如需要)

6. Perform and deliver quality activities assigned.

执行其他安排的质量活动

Quality systems management

质量体系管理

1. Draft, review and approve GMP document to make sure in compliance with GMP requirement

起草，审核和批准GMP文件确保符合GMP的要求

2. Own QAF/Site procedure, secure operation GMP compliance

负责QAF/ Site 流程，确保运行的高度符合GMP

3. Quality assessment of cross function change and lead QAF change execution

负责跨部门的变更评估和QAF 变更的实施

Quality continuous improvement

质量的持续改进

Management

人员管理

Lead daily work in each team

领导质量保证团队的日常工作

Work instruction and help to team members

对团队成员给予必要的工作指导

Build and develop team capability

建立和发展推对团队能力

Provide daily performance feedback to team members

提供团队成员的日常绩效反馈

SHE responsibilities

SHE 相关职责

Identify and understand the SHE risk factors within the department.

识别和认识本部门的安全危险因素

Develop and carry out plans to address the key SHE issues in the associated areas and ensure the follow up actions are carried out.

制定和执行SHE方案以强调在相应区域的关键SHE事件并确保跟进

措施的落实执行。

Education, Qualifications, Experience and Capabilities 教育、资质、经验和能力

Education, Qualification, Experience

教育、资质、经验

Essential 必 需

University graduate, major in pharmaceutical or related subjects

大学毕业，药学或相关学科

5 years of QA or production working experience

5 年以上QA 或生产工作经验

- Desirable 理 想

8 years of QA working experience

8 年以上QA 工作经验

Have multiple national enterprise working experience

外企工作经验

Cross Function working experience

跨部门工作经验

Capabilities

能力

Solid GMP and quality system management knowledge 良好的GMP 和质量体系管理知识

Familiar with up-to-date technology and regulatory trend 熟悉行业技术和法规

Familiar with quality risk management 熟悉质量风险管理专家

Knowledge of process control methodology and statistics, for example Cpk, FMEA 具备过程控制方法和统计学的知识，类似Cpk, FEMA 等工具

Working knowledge of Microsoft applications, SAP or similar system 熟悉微软应用，SAP 或类似系统

Good English 英语水平良好

Good Computer skill 电脑使用熟练

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

Date Posted

03-Nov-2026

Closing Date

30-Mar-2027

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.