QC Group leader of physical and chemical instruments
- Work location
- Room A708, Building 1, No.600 Huaxi Road, Minhang District, Shanghai
- Job type
- Management position
- Job responsibilities
- 1. Responsible for formulating or revising the quality standards of raw materials, packaging materials, intermediates, finished products and process water for new products together with the technical department and pharmaceutical research Institute;
2, organize new product registration batch, process verification batch related raw materials, intermediate products and finished product inspection, and data summary, analysis and review;
3. Responsible for the transfer, confirmation or verification of analytical methods;
4. Responsible for OOS investigation, analysis, processing and reporting;
5, responsible for the technical support of foreign project inspection;
6, responsible for the domestic and foreign pharmacopoeia and related regulations of the update;
7. Assisted QC supervisor to complete the self-inspection of the quality system of the department
8, assist the QC supervisor to organize the business training of the quality inspection personnel of the department;
9. Complete other work arranged by QC supervisor;
- Qualification
- 1, pharmacy related major, bachelor degree or above;
2, more than 5 years of human drug testing experience, more than 2 years of analytical method verification or confirmation experience
3, familiar with HPLC, GC and other precision instrument operation;
4, strong ability to resist pressure, clear thinking logic, proficient in QC laboratory GMP and other regulatory requirements.