l Management of test samples: In-process and release samples, environmental testing samples and drug substance and excipient samples
l Stability sample management.
l Regulatory retain sample management.
l Reference sample management
l 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.
l 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.
lA good understanding of the overall view of drug development process.
l A thorough understanding of the principles and management of cGMP compliance, and strong quality minds.
l Comprehensive knowledge in FDA, EMA, NMPA, ICH, WHO technical guideline and USP, Eur.P, ChP pharmacopoeias.
l Comprehensive knowledge in IND/IMPD, NDA and ANDA filing
l Full time on-site work requirements
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