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Quality Control Analyst

Salary undisclosed

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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