Job Description

Responsibilities:

Responsible for electronic system application, including but not limit to LIMS, Cispro, LES, SAP, Maximo and Empower.
Serve as SME for electronic system and collaborate with global functions.
Serve as SME during audit
Performing training to QC users, external functions
Perform troubleshooting when necessary
Ensure all the activities in QC team performed with compliance of cGMP, data integrity and EHS requirement.

Requirements:

Bachelor degree or above in pharmacy, chemistry, biochemistry, analytical chemistry or other related discipline
With 6 - 12 years in biotech or biopharma
Deep understanding of FDA, EMA, ICH related regulations
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