Engineer, QC
Responsibilities:
- 为项目和工厂提供质量专业知识支持。
- 协助 GPQS、ECMS、GVLMS 数据库的开发并提供专业知识。
- 支持和推动必要的部门流程、文档和培训。
- 支持和维护技术能力，并与工程、IT、QA、制造和技术职能部门的同行合作，在指定的项目和活动中提供质量监督。
- 支持 GMP 相关设施和设备系统的质量控制工作，以确保完全符合 GMP。
- 严格执行岗位操作规程和指南，完成日常实验。
- 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
- 根据业务需要完成安排的其他工作
- Provide quality expertise support for the project and the plant.
- Support the development of GPQS, ECMS, and GVLMS databases, providing expertise.
- Support and drive necessary departmental processes, documentation, and training.
- Support and maintain technical capabilities, and collaborate with peers in engineering, IT, QA, manufacturing, and technical functions to provide quality oversight in designated projects and activities.
- Support quality control work for GMP-related facilities and equipment systems to ensure full compliance with GMP.
- Follow job operating procedures and guidelines to complete daily experiments.
- Participate in GMP training and strictly comply with GMP and regulatory requirements.
- Develop various work skills and pursue continuous improvement.
Requirements:
- 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基本知识。
- 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 basic 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
- 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.
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.
