[武汉]鼎康（武汉）生物医药有限公司

岗位描述：
? Participate in the daily activities of the Cell Culture Manufacturing Group. Apply proper PPE (Personal Protective Equipment) to all work in the facility;
参与细胞培养组的日常生产活动，应用适当的个人防护用品去完成在厂房内的所有工作；
? Participate in the evaluation of new technology, new production process and new production technology;
参与评估新工艺、新生产流程和新生产技术；
? Escalate process issues as necessary to ensure resolution.
根据需要逐步优化工艺中的问题并保证解决问题。
? Author MGC-CC GMP documents, ensure GMP training requirements are complete and current.
起草生产部细胞培养组的GMP文件，确保GMP培训要求以及完成和更新；
? Familiar with the handle process of quality events such as deviation, CAPA and change control.
熟悉偏差，CAPA和变更等质量事件的处理流程；
? Ensure operations strictly adhere to all SOPs and cGMP/Quality requirements.
保证严格根据所有的SOPs和cGMP/质量要求来操作；
? Ensure all work is performed in safe manner, the operation complies with EHS requirements and meets the specifications for each service request.
确保安全的方式去执行所有的工作，操作复核EHS要求，并符合各个服务请求的标准；
? Production process monitoring ，review documentation and check all calculations (e.g. batch records, labels, equipment reading).
生产过程的监控，审阅文件，检查所有的计算（例如批记录，标签，设备的读数等）；
? Clean and maintain the GMP facility and production equipment, maintenance of environmental and personal hygiene.
清洁和维护GMP厂房和生产设备,保持环境和个人卫生；
? Participate in the internal auditing program for company as required; Serve as department representative on cross-functional teams.
根据需要参与公司的内部审计计划；能够担任跨职能团队的部门代表。