Overview
Engineer, QA Jobs in Qingdao, Shandong, China at AstraZeneca
Title: Engineer, QA
Company: AstraZeneca
Location: Qingdao, Shandong, China
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.
