职位描述
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.
