QC仪器管理员

Responsibilities 1. 负责完成各项仪器、系统的管理工作，支持公司业务发展。 Responsible for the management of various instruments and systems and support the business development of the company. 2. 负责完成设备相关的采购、验证、校验/计量、维护和维修工作。 Responsible for the procurement, validation, calibration/measurement, maintenance and repair of equipment. 3. 负责协助IT团队完成对GMP局域网内QC系统以及相关硬件设备的采购、验证和维护工作。 Responsible for assisting the IT team in the procurement, validation, and maintenance of the QC system and related hardware equipment within the GMP local area network. 4. 负责起草、撰写和审核与仪器相关变更和偏差，确保部门工作符合法规和公司要求。 Be responsible for drafting, writing and reviewing instrument change and deviation to ensure department work in compliance with regulations and company requirements. 5. 协助完成流程平台建设、流程优化等相关工作。 Assist to complete the process platform construction, process optimization and other related work. 6. 负责完成QC计算机化系统相关工作并组织完成年度计算机化系统回顾。 Responsible for completing tasks related to the QC Computerized System and organizing the annual review of the Computerized System. 7. 负责完成LIMS/ELN相关工作。 Responsible for completing tasks related to LIMS/ELN. 8. 完成上级安排的其他工作。 Perform other tasks assigned by superior. 任职资格 1. 大专学历及以上。 College degree or above. 2. 熟悉QC各仪器系统软件、硬件相关操作。 Familiar with the operation of various QC instrument systems' software and hardware. 3. 熟悉LIMS\ELN软件系统相关操作。 Familiar with the operation of LIMS/ELN software systems. 4. 熟悉各类仪器维修、维护、确认。 Familiar with the repair, maintenance, and validation of various instruments. 5. 熟悉现行法规对计算机化系统验证和数据可靠性的要求。 Familiar with current regulatory requirements for computerized system validation and data integrity. 6. 高度的工作热情，良好的团队合作精神，能够独立工作并能承受一定的工作压力。 Highly enthusiastic, good team player, able to work independently and under pressure. 7. 为人正直严谨，具备良好的沟通能力。 Honest and rigorous, with good communication skills. 8. 具备一定的英语水平，能阅读英语专业资料,具备基本的计算机操作技能。 Possess a certain level of English proficiency, be able to read professional English materials, and have basic computer operation skills.