Specialist II Quality Control

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  • 山东省-青岛

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.