职位详情
制剂灌装生产工程师
5千-8千
鼎康(武汉)生物医药有限公司
武汉
1-3年
不限
10-15
工作地址

湖北省武汉市东湖开发区高新二路388号

职位描述
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.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;
2.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;
3.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;
4.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;
5.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;
6.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;
7.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;
8.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;
9.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;
10.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)。

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