QA Senior Specialist
Typical Accountabilities
主要职责
• 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. Product releaser
产品放行
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
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
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 authorisation and employment eligibility verification requirements.
