北京招聘

职位描述：
制剂研究组长/高级研究员Sr. Scientist（集团医药板块）

工作职责：
1. 通过专利及文献检索，评估科研管理处初步拟定的项目，然后进行立项；
2. 负责各项目的处方工艺开发工作，完成CTD资料，同事协助分析师完成项目的质量研究工作；
3. 负责到工厂进行三批中试样品的生产，并负责审核工艺验证和清洁验证方案；
4. 制定实验室管理规范、仪器设备使用SOP；
5. 熟悉转移项目的处方、工艺、质量标准，原辅料及包材规格、生产设备等相关信息。起草ANDA项目立项申请；
6. 拟定工艺验证方案及分析方法验证/确认方案，协调研发部、生产部、QA、QC的工作，推进项目的进行；
7. 负责各项验证试验评估报告的撰写；
8. 按ANDA/WHO要求整理所有申报资料；
9. 做要迎接FDA、WHO官员检查的准备。

任职要求：
1. 药物化学、生物制药等相关专业硕士及以上学历；
2. 熟悉GMP、ICH等相关法规；
3. 具备2年以上药物制剂研究经验，资深者可考虑研究组长职务；
4. 熟悉CFDA对上市前现场批制剂部分的审计要求；
5. 英语读写能力良好。 举报 分享

Andala Co. Ltd. is a well-known company with years of development in China. Its sales turnover and profit always rank at top in the Industry.

Guangzhou Andala Co. Ltd. aims at providing the efficient solution for supply chain with business in technology, FMCG, retailing, fashion, medicine, automotive, chemicals, aviation Industry and other industrial sectors. Headquarter of Guangzhou Andala Co. Ltd. locates in Guangzhou with branches in Shanghai and Beijing. The Company is trying to provide the most efficient one-stop service for the customers. We are committed to become a first-class multinational group.

Guangzhou Andala Co. Ltd. establishes a business network in many cities in China. With good reputation, Guangzhou Andala Co. Ltd. has been widely recognized and praised with its excellent service and continuously improved management systems. We will do all means to respect, take care of and motivate our staff to create an enjoyable environment.

As our business is expanding quickly now, we sincerely invite competent and self-motivated individuals to join our team. We offer attractive remuneration package and career development opportunities to successful candidates. Candidates please send your applications with detail resume both in Chinese and English, recent photo, expected salary and contact number to our designated email address: hrjob88@foxmail.com
有意者请将个人简历发至邮箱：hrjob88@foxmail.com,谢谢合作!应聘资料将予保密。