高级QC专员
Bayer
- Beijing
- Permanent
- Full-time
- Responsible for validation on the analytical method of the new product, including create/develop product analytical method and test method for cleaning validation.
- Responsible for analytical method transfer as QC leader, including establishment of transfer protocol, implement transfer test and compiling report.
- Organize resource and implement validation test activities of new product and product transfer.
- Provide technical support to other department including Regulatory department and Government affairs department.
- Independently test of bulk, stability research, validation (including production validation and cleaning validation) and cleaning monitor according to approved test procedure and specification.
- Track and keep KPIs to meet with project schedule and controlling department.
- Revise SOPs and test procedures according to project requirement /BAG directives/regulations/SOPs and Pharmacopoeia or registration specification.
- Education: Bachelor's degree of pharmaceutical science or related.
- Experience: More than 5 years' experience in the pharmaceutical company.
- Knowledge & Skills: 1.Familiar with Chinese GMP and EU GMP. 2.Good operational skills on lab instruments (HPLC, GC, IR, UV, AAS, electronic titrator, etc.). 3.Project management experience, including product transfer, AMT, etc, 4.Strong teamwork spirit o Well communication, presentation,and interpersonal skills. 5.Fluent in English speaking and writing.