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制剂灌装生产工程师
5-8千
人 · 大专 · 1年及以上工作经验 · 性别不限2025/01/16发布
五险一金定期体检免费班车年终奖金弹性工作专业培训周末双休自助午餐英文工作环境

东湖新技术产业开发区

低价好房出租>>

鼎康(武汉)生物医药有限公司

公司信息
鼎康(武汉)生物医药有限公司

外资(非欧美)/150-500人

该公司所有职位
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.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。

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