GMP Consultant/Specialist
Job location: Shanghai
Contract duration: 6 months (with possibility to extend)
CLIENT PROFILE
Our client is a multinational EPCM with long term commitment in China. The major focus is pharmaceutical and energy industry. With head office in Shanghai, they have projects running across the country. They have 200+ staff and a healthy project pipeline.
THE ROLE
This role will be assigned to one of their MNC pharmaceutical clients who is investing heavily in Beijing. The project is now in basic design stage. It would be a 6-month contract initially and might be extended according to current project status and other projects' situation.
Job Responsibilities
- Ensure regulatory compliance and efficient workflows within the facility.
- Making sure the design of cleanroom or GMP facility adheres to the correct standards.
- Lead meetings with client and the engineering design team regarding GMP topics.
- Support client for GMP reviews, including GMP concept, flows (people, material, product, wastes), layout, pressure zoning, etc.
- Support client for the review of other key quality documents (for instance contamination control strategy, bioburden control philosophy, etc.)
- Other GMP related tasks
WHAT WE EXPECT OF YOU
- Bachelor degree or above in pharmaceutical engineering or related field.
- 10+ years' experience in GMP activities (such as production, facility design or quality)
- Expertise in Chinese GMP, and European and American GMP is a plus.
- Good communication and presentation skills both externally and internally
- Both Chinese and English language skill in speaking and writing.