CB06-GMP Training Specialist
凯惠睿智生物科技有限公司ShanghaiUpdate time: June 2,2019
Job Description
Job Purpose 岗位目的:
  • Responsible for site-wide compliance training, ensuring employees are appropriately qualified to perform their jobs and all GMP training requirements are met
  • Ensure GMP training records are properly organized, filed, maintained and kept current
Responsibilities:
  • Prepare site training procedure according to the requirements of the QMS, and ensure the training process smoothly. 按照QMS的要求,制订培训管理流程,保证培训工作的顺利进行。
  • Responsible for organizing the annual compliance training programs and to coordinate the organization and implementation. 负责组织年度合规培训计划并协调组织实施。
  • Responsible for basic GMP training. 负责新员工岗前GMP基础培训。
  • Responsible for the establishment of a compliance training file system, and ensuring employees keep up their training records 负责建立培训档案,做好培训记录和材料的归档工作。
  • Maintain CAPA system to implement continuous improvement. 维护和管理CAPA体系,实现持续改进。
  • Participate in annual product review. Review appropriate QMS to ensure in place and in use. 参与产品年度回顾分析, 对负责的体系进行定期回顾,确保有效实施。
  • Collect the regulatory requirement and complete the assigned work efficiently 及时收集了解法律法规信息,组织完成相应工作。
  • Other temporary work.其他工作。

Requirements:
  • Breadth & depth across disciplines or functions; expertise in field required
  • Graduated in Life Science field
  • Minimum 5 years experience of application of GMP to pharmaceuticals manufacturing processes
  • 2+ years in QA management or GMP training role Good communication and coordination skill
  • Good command of English and computer skill
  • Good training skill.

职能类别: 药品生产/质量管理

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