青岛招聘

The role

1. Train and direct factories to meet current requirements of FDA/ICH and other regulations.

对工厂进行培训或指导，使之符合FDA/ICH的以及其他药政法规

2. Guide and Lead assigned factories to understand and meet cGMP compliance.

指导并带领协议工厂了解并符合cGMP法规。

3. Guide factories to prepare the DMF/EDMF/COS/annual report/deficiency response or other necessary documents.

指导工厂准备DMF/EDMF/COS/年度回顾/缺陷回复或其他必要文件。

4. Prepare and participate in FDA/EDQM inspection or customer audits.

准备并参与FDA/EDQM检查或客户审计。

5. Conduct the factory cGMP compliance assessment as arranged.

执行对工厂的cGMP法规符合性评估计划。

6. Project management/product development ensuring timelines are met and projects are move smoothly to commercialization.

保证项目管理/产品开发能按时、按标准顺利进行并商业化。

7. Handle the request on the application and technical issues arising from the customers and the regulatory agencies.

处理客户和法规代理对申请和技术提出的问题

8. Conduct training for the factories as required.

推进对工厂的协议培训。

Experience 岗位要求

Requirements基本要求

- Excellent spoken and written English and Chinese.熟练的英语和中文说写能力

- Negotiating experience in both English and Chinese良好的英语和中文谈判能力

- Demonstrable track record of follow-up and delivering on commitments对项目的追踪、跟进和履行能力

- University degree大学学历

- Minimum 3 years experience working in regulatory and compliance area 至少具有3年的药政相关工作经历

- Good inter-personal skills and ability to multitask.具备优秀的人际沟通能力和具备良好的业务能力

Desirable 条件

- Working experience in pharmaceutical industry具有制药行业工作背景

- University degree in Chemistry or pharmacy 药学和化学专业大学学历

Skills 技能

- Able to manage projects and prioritize the workload 具有项目管理能力和按照工作重要性进行工作安排的能力

- Adaptability and Flexibility – must be prepared to ‘get their hands dirty’ Highly professional in appearance and manner 优秀的环境适应能力和职业素养

- Good analytical ability良好的分析能力

- An eye for detail but the vision to see the ‘big picture’ 具有战略眼光并能注重细节

工作地点：青岛

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Rochem International Inc., is a leading distributor of Pharmaceutical, Nutritional and Food ingredients to Europe and the Americas, founded in 1994. We operate out of 11 offices worldwide including Qingdao, China. ROCHEM's elite team of employees have all been carefully chosen and have extensive knowledge and experience in the pharmaceutical and food industries.

ROCHEM International Inc. is a bridge to quality pharmaceutical, food and nutritional ingredients. Our expertise is in sourcing raw materials from our unrivaled network of suppliers in China, to our customers in North America and Europe. We also provide top level regulatory and compliance support as a competitive advantage to both suppliers and customers.
ROCHEM has an environment where individuals can bring their unique talents to be welcomed and embraced. Our employees are truly the cornerstones of our success. You will enjoy our team spirit and the opportunity for your continued professional growth. At ROCHEM it is not just a job, it's a career.
More detail please visit our web：www.rochemintl.com .

If you are motivated and focused individual looking for a challenging and rewarding career then consider joining our professional team. Please Contact:
RochemHR@126.com
No response will be expected if not considered.