QC Metrology

To support and oversee Metrology works in QC
instrument/equipment routine maintenance instrument/equipment qualification/requalification/retirement instrument/equipment data backup & archival instrument/equipment account management documentation updates 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 color meter. Responsible for electronic system application, including but not limited to LIMS, EMPOWER and LES. Ensure all the activities in QC team performed with compliance of cGMP, data integrity and EHS requirement.
Skills 1. A good understanding of the overall view of drug development process.
2. A thorough understanding of the principles and management of cGMP compliance, and strong quality minds.
3. Comprehensive knowledge in FDA, EMA, NMPA, ICH, WHO technical guideline and USP, Eur.P, ChP pharmacopoeias.
4. Comprehensive knowledge in IND/IMPD, NDA and ANDA filing