工作职责: 1.Perform production work of DP1 or/and DP2. 执行制剂一厂或/和制剂二厂的制剂生产工作; 2.Responsible for DS thawing, preparation, vial washing, sterilization, compounding, sterile filtration, filling, freeze-drying and capping. 负责原液解冻、生产准备、洗瓶、灭菌、配制、除菌过滤、灌装、冻干、轧盖工序; 3.Responsible for the preparation of disinfectants. 负责消毒剂的配制; 4.Responsible for the receiving and distribution of production materials. 负责生产材料的领取和发放; 5.Responsible for the cleaning and disinfection of rooms and equipment in the responsible area. 负责责任区域的房间和设备清洁和消毒; 6.Generate and review documents for related manufacturing processes. 起草和审核相关步骤生产流程文件; 7.Ensure operations strictly adhere to all QA-Controlled documents (such as SOPs, Batch Records) and cGMP/Quality requirements. 确保操作严格遵守所有QA控制文件(例如SOP、批记录)和cGMP/质量要求; 8. Clean and maintain the GMP facility and production equipment, assist to complete preventive maintenance of equipment. 清洁并维护GMP设施和生产设备,配合完成设备预防性维护; 9. Responsible for equipment revalidation and APS. 负责设备再验证和APS的执行; 10. Responsible for the submission requirements of the production materials for the post. 负责本岗生产用物料的提交需求; 11. Responsible for completing various trainings organized by the workshop and the company on time. 负责按时完成车间及公司组织的各项培训; 12. Ensure Safety manufacturing. 确保安全生产; 13. Ensure that drug product manufacturing conforms to written procedures of Chime biologics. 确保生产过程符合公司的书面流程; 14. Complete other tasks assigned by Immediate superior. 完成上级领导安排的其他任务。
任职资格: 1.Be familiar with the pharmaceutical industry, and willing to engage to biopharmaceutical industry, good learning ability and good team spirit. 对制药行业有一定认识,并且愿意从事生物医药行业,学习能力强和好的团队意识; 2.Be familiar with the production equipment and process of small volume injections and freeze-dried preparations. 熟悉小容量注射剂和冻干制剂生产设备和工艺; 3.At least 1 years of non-final sterilization injection production or quality management experience. 至少1年以上非最终灭菌注射剂生产或质量工作经验; 4.Be aware of certain aseptic operation, drug production knowledge and excellent academic record in school. 有一定的无菌操作知识及药品生产知识,在校学习成绩优秀; 5.Capable of writing detailed reports and summaries and exhibit detail oriented documentation skills. 能够编写详细的报告和总结,掌握良好的文档处理技术; 6.Communicate effectively and work professionally in a team environment. 能够在团队中进行有效沟通和专业工作; 7. Skilled in the use of computers and automation-drive equipment. 熟练使用计算机和自动化驱动设备; 8. Must be flexible to work on any shift (day, night, weekend) and able to work prolong duration on your feet. 必须适应灵活的工作班次(白班、夜班、周末),接受加班; 9. Good oral and written communication skills in English and Mandarin (Read, Write, Verbal). 良好的中英文口头和书面交流能力(阅读、写作、口语); 10.Graduating students or in school students with college degree or above who major in biological, pharmacy, chemistry or engineering. 生物,药学,化学或者工程类大专及以上学历应届毕业生,或者在校学生。