Senior QA Specialist（验证）
职位任职者将
• 提供质量支持以实现 pMDI 项目里程碑。
• 负责确保在青岛资本项目计划的设计、施工、启动、验证（整个生命周期）期间符合
GMP 要求。
• 确保验证计划（设施、设备、公用设施资格；计算机系统验证、清洁验证或工艺验证）符
合 GMP 并具有操作有效性。
• 参与与运营和质量部门内部和外部同事的跨职能互动。
• 指导、培训和培养 QA 和其他工程/运营人员以及相关技术科目的实习生，是 GMP 培训活
动的主要贡献者。
• 根据需要监督和监督承包商和实习生的活动
The role incumbent will
• Provide Quality support to achieve the pMDI project milestones.
• Responsible for ensuring compliance with GMP requirements during the design,
construction, start-up, validation (entire life-cycle) of Qingdao capital project initiative.
• Ensuring GMP compliance and operational effectiveness of the validation program
(facility, equipment, utility qualifications; computer system validation, cleaning validation
or process validation).
• Participate in cross functional interaction with both internal and external colleagues in
Operations and Quality.
• Mentor, train, and develop QA and other engineering / operations staff and interns in
relevant technical subjects and is a key contributor to GMP training activities.
• Supervise and oversight contractors and intern activities as required
• 提供质量支持以实现 pMDI 项目里程碑。
• 负责确保在青岛资本项目计划的设计、施工、启动、验证（整个生命周期）期间符合
GMP 要求。
• 确保验证计划（设施、设备、公用设施资格；计算机系统验证、清洁验证或工艺验证）符
合 GMP 并具有操作有效性。
• 参与与运营和质量部门内部和外部同事的跨职能互动。
• 指导、培训和培养 QA 和其他工程/运营人员以及相关技术科目的实习生，是 GMP 培训活
动的主要贡献者。
• 根据需要监督和监督承包商和实习生的活动
The role incumbent will
• Provide Quality support to achieve the pMDI project milestones.
• Responsible for ensuring compliance with GMP requirements during the design,
construction, start-up, validation (entire life-cycle) of Qingdao capital project initiative.
• Ensuring GMP compliance and operational effectiveness of the validation program
(facility, equipment, utility qualifications; computer system validation, cleaning validation
or process validation).
• Participate in cross functional interaction with both internal and external colleagues in
Operations and Quality.
• Mentor, train, and develop QA and other engineering / operations staff and interns in
relevant technical subjects and is a key contributor to GMP training activities.
• Supervise and oversight contractors and intern activities as required
职责（包括关键结果领域、具体责任、任务等） Job Responsibilities (to include key result
areas, specific accountabilities, tasks, etc.)
• 为项目和后续站点提供质量专业知识。
• 提出解决方案选项以改进和/或解决技术挑战。
• 支持 GPQS、ECMS、GVLMS 数据库的开发并提供监督和专业知识。
• 提供 QMS 所有权，包括青岛运营站点内的验证、变更控制、偏差和相关基础设施活动。
areas, specific accountabilities, tasks, etc.)
• 为项目和后续站点提供质量专业知识。
• 提出解决方案选项以改进和/或解决技术挑战。
• 支持 GPQS、ECMS、GVLMS 数据库的开发并提供监督和专业知识。
• 提供 QMS 所有权，包括青岛运营站点内的验证、变更控制、偏差和相关基础设施活动。
与资本项目的工程 IT、QC、制造和技术功能进行交互，并在项目的设计、施工和启动阶
段主动确保符合 GMP。
• 开发和推动必要的部门流程、文档和培训。
• Provide Quality expertise to the project and later site.
• Propose solution options to improve and/or resolve technical challenges.
• Support development of GPQS, ECMS, GVLMS database and provide oversight and
expertise.
• Provide ownership of QMS including validation, change controls, deviations, and related
infrastructure activities within the Qingdao Operations site.
• Interface with engineering IT, QC, manufacturing, and technical functions on capital
projects and proactively ensure GMP compliance during the design, construction and
start up phases of the project.
• Develop and drive necessary departmental process, documentation and training.
段主动确保符合 GMP。
• 开发和推动必要的部门流程、文档和培训。
• Provide Quality expertise to the project and later site.
• Propose solution options to improve and/or resolve technical challenges.
• Support development of GPQS, ECMS, GVLMS database and provide oversight and
expertise.
• Provide ownership of QMS including validation, change controls, deviations, and related
infrastructure activities within the Qingdao Operations site.
• Interface with engineering IT, QC, manufacturing, and technical functions on capital
projects and proactively ensure GMP compliance during the design, construction and
start up phases of the project.
• Develop and drive necessary departmental process, documentation and training.
典型职责（根据 AZ 框架和监管要求）Typical Accountabilities (per AZ framework and
regulatory expectations)
• 开展符合公司价值观的活动和互动，并遵守与您的职位相关的道德规范和支持政策和标准
（包括 SHE）。按时完成 AZ 道德规范和支持政策和标准的所有必需培训。报告潜在的不
合规问题。
• Conduct activities and interactions consistent with Company Values and in compliance
with the Code of Ethics and supporting Policies and Standards relevant to your role
(including SHE). Complete all required training on the AZ Code of Ethics and supporting
Policies and Standards on time. Report potential issues of non-compliance.
regulatory expectations)
• 开展符合公司价值观的活动和互动，并遵守与您的职位相关的道德规范和支持政策和标准
（包括 SHE）。按时完成 AZ 道德规范和支持政策和标准的所有必需培训。报告潜在的不
合规问题。
• Conduct activities and interactions consistent with Company Values and in compliance
with the Code of Ethics and supporting Policies and Standards relevant to your role
(including SHE). Complete all required training on the AZ Code of Ethics and supporting
Policies and Standards on time. Report potential issues of non-compliance.
教育、资历、技能和经验Education, Qualifications, Skills and Experience
必备条件Essential
• 拥有学士学位，并在药品质量、制造、技术或监管岗位方面拥有丰富的相关经验。
• 熟悉 cGMP 和全球 GMP 要求、质量体系以及药品制造和/或包装拥有用于管理质量数据的典型电子系统的实践经验。
• 很好地理解计算机验证要求和 21 CFR 11要求。
• 人际交往和解决问题的能力很强。
• 表现出独立和协作处理多学科和多功能工作的能力。
• 使用中文和英文作为工作语言。
• 具有出色的口头和书面沟通能力，能够与组织各个级别的个人进行有效沟通。
• Bachelor’s degree and substantial relevant experience in pharmaceutical
quality, manufacturing, technical or regulatory roles.
• A good knowledge of cGMPs and global GMP requirements, quality systems, and
pharmaceutical manufacturing and/or packaging
• Own practical experience with typical electronic systems used for managing
Quality data.
• Good understanding of computer validation requirements and 21 CFR 11 requirements.
• Well -developed interpersonal and problem solving skills.
• Demonstrated ability to work independently and collaboratively on
multidisciplinary and multifunctional.
• Use both Chinese and English as working language.
• Excellent oral and written communication skills with the ability to communicate
effectively with individuals from all levels of the organization.
• 拥有学士学位，并在药品质量、制造、技术或监管岗位方面拥有丰富的相关经验。
• 熟悉 cGMP 和全球 GMP 要求、质量体系以及药品制造和/或包装拥有用于管理质量数据的典型电子系统的实践经验。
• 很好地理解计算机验证要求和 21 CFR 11要求。
• 人际交往和解决问题的能力很强。
• 表现出独立和协作处理多学科和多功能工作的能力。
• 使用中文和英文作为工作语言。
• 具有出色的口头和书面沟通能力，能够与组织各个级别的个人进行有效沟通。
• Bachelor’s degree and substantial relevant experience in pharmaceutical
quality, manufacturing, technical or regulatory roles.
• A good knowledge of cGMPs and global GMP requirements, quality systems, and
pharmaceutical manufacturing and/or packaging
• Own practical experience with typical electronic systems used for managing
Quality data.
• Good understanding of computer validation requirements and 21 CFR 11 requirements.
• Well -developed interpersonal and problem solving skills.
• Demonstrated ability to work independently and collaboratively on
multidisciplinary and multifunctional.
• Use both Chinese and English as working language.
• Excellent oral and written communication skills with the ability to communicate
effectively with individuals from all levels of the organization.
优先条件Desirable
• 在中国境外生活和工作
• 在复杂多变的商业环境中的经验
• 设备制造/质量监督/管理经验
• 深入了解制药制造设备和控制、暖通空调、纯净水和相关公用设施系统
• 在复杂多变的商业环境中的经验
• 设备制造/质量监督/管理经验
• 深入了解制药制造设备和控制、暖通空调、纯净水和相关公用设施系统
精益/6 sigma 和应用经验
• 深入的项目管理经验
• Lived and worked outside of China
• Experience within a complex dynamic business environment
• Device manufacturing/quality supervisory/management experience
• In-depth understanding of pharmaceutical manufacturing equipment and controls, HVAC, purified water, and related utility systems
• Lean / six sigma manufacturing training and applied experience
• In-depth experience with project management
• 深入的项目管理经验
• Lived and worked outside of China
• Experience within a complex dynamic business environment
• Device manufacturing/quality supervisory/management experience
• In-depth understanding of pharmaceutical manufacturing equipment and controls, HVAC, purified water, and related utility systems
• Lean / six sigma manufacturing training and applied experience
• In-depth experience with project management
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.
