Engineer, QA

职位的任职者将

• 提供质量支持以实现 pMDI 项目里程碑。
• 确保青岛pMDI 项目计划在设计、施工、启动、验证（整个生命周期）期间符合 GMP 要求。
• 确保自有业务中验证计划的 GMP 合规性和运营有效性
• 与运营和质量部门的内部和外部同事进行跨职能互动，以确保完全符合 AZ 标准和当地法规。
• 支持 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。
• 与AZ 总部或跨职能部门合作，确保全球项目或青岛数字化、自主化项目的落地
• 根据需要支持监督和监督承包商和实习生活动 The role incumbent will
• Provide Quality support to achieve the pMDI project milestones.
• 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 within owning business.
• Cross functional interaction with both internal and external colleagues in Operations and Quality to ensure full compliance with AZ standards and local regulations.
• Support QA and other engineering / operations staff and interns in relevant technical subjects and is a key contributor to GMP training activities.
• Collaborate with AZ headquarters or cross-functional departments to ensure the implementation of global projects or Qingdao digitalization and autonomy projects.
• Support the 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.)

• 为项目和工厂提供质量支持。
• 支持 GPQS、ECMS、GVLMS 数据库的开发。
• 参与青岛供应基地内 QMS 的建立，包括验证、变更控制、偏差和相关基础设施活动。

与pMDI 项目的工程 IT、QC、制造和技术功能进行对接，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。
• 开发和维护技术能力，并与工程、IT、QC、制造和技术职能部门的同行合作。
• 支持 GMP 相关设施和设备系统的质量保证工作，以确保完全符合 GMP。
• 参加GMP 培训，严格遵守GMP 与法规要求
• 发展各种工作技能并追求持续的改进，参与并支持数字化和自主化项目。
• 根据业务需要完成安排的其他工作
• Provide quality support to the project and later site.
• Support development of GPQS, ECMS, GVLMS database.
• Participated in the building up 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.
• Develops and maintains technical competency and collaborates with counterparts in engineering, IT, QC, manufacturing, and technical functions.
• Supports quality assurance efforts for GMP related facility and equipment systems to ensure full GMP compliance.
• Participate in GMP training and strictly comply with GMP and regulatory requirements.
• Develop various work skills and pursue continuous improvement, participate in and support digital, and autonomous projects.
• Complete other work assigned according to business needs.

教育、资历、技能和经验

Education, Qualifications, Skills and Experience

必备条件Essential 优先条件Desirable

• 拥有学士学位，并具备药品质量、制造、技术的一般经验。
• 具备 cGMP 和全球 GMP 要求、质量体系 以及药品/设备测试技术和药典的充分知识。
• 具备计算机验证和21 CFR 11的基本知识。
• 具备良好的人际交往和解决问题的能力。
• 具备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。
• 具备出色的口头和书面沟通能力，能够与 组织各个级别的人员进行有效沟通。
• Bachelor’s degree and general experience in pharmaceutical quality, manufacturing, or technical roles.
• A good knowledge of cGMPs and global GMP requirements, quality systems, and pharmaceutical product/device testing technology and pharmacopeia. Well -developed interpersonal and problem solving skills.
• A basic knowledge of computer validation requirements and 21 CFR 11 requirements.
• 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.

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.