Apply on
Original
Simplified
Role Function: QC Testing
Work Location: Tuas Biomedical Park
Responsibilities:
- Responsible for raw material testing, in-process control (IPC), environmental monitoring, water testing, and finished products testing
- Ensure proficiency in HPLC and GC operations and troubleshooting, CE-SDS, cIEF, cell-based potency assays, and ELISA-based qualification
- Perform Karl Fischer titration, Total Organic Carbon (TOC) testing, UV-Vis spectrophotometry, and FTIR
- Conduct manual and automatic titration, bioburden testing, sterility testing, Container Closure Integrity Testing (CCIT), and endotoxin testing
Qualifications:
- Bachelor’s degree or above in pharmacy, chemistry, biochemistry, analytical chemistry, or other related disciplines
- Minimum of 2 years of experience in the biotech or biopharma industry
- A good understanding of the overall drug development process
- A thorough understanding of the principles and management of cGMP compliance, and a strong quality mindset
- Comprehensive knowledge of FDA, EMA, NMPA, ICH, WHO technical guidelines, and USP, Eur.P, ChP pharmacopoeias
- Comprehensive knowledge of IND/IMPD, NDA, and ANDA filing
- Proficiency in English as a working language
Similar Jobs