- Management of test samples: In-process and release samples, environmental testing samples and drug substance and excipient samples
- Stability sample management.
- Regulatory retain sample management.
- Reference sample management
- Responsible for QC instrument and equipment management, like C type instruments including HPLC, GC, IC and LC-MS and B type instruments pH, balance and colorimeter.
- Responsible for electronic system application, including but not limit to LIMS, EMPOWER and LES.
- Ensure all the activities in QC team performed with compliance of cGMP, data integrity and EHS requirement.
Other special requirements:
- A good understanding of the overall view of drug development process.
- A thorough understanding of the principles and management of cGMP compliance, and strong quality minds.
- Comprehensive knowledge in FDA, EMA, NMPA, ICH, WHO technical guideline and USP, Eur.P, ChP pharmacopoeias.
- Comprehensive knowledge in IND/IMPD, NDA and ANDA filing
- Full time on-site work requirements