QC Qualification Engineer

NO DEVIATION PTE. LTD.

Jurong Island, Singapore
Mass spectrometry qualification
Ftir equipment qualification
Computer system validation csv
The role focuses on ensuring Quality Control instruments and computerized systems meet strict GMP/GxP compliance standards

Job Summary

  • The role focuses on ensuring Quality Control instruments and computerized systems meet strict GMP/GxP compliance standards.
  • Candidates will drive equipment qualification processes including URS, IOQ, PQ, and change control management for analytical instruments.
  • The company offers a comprehensive health and wellness package along with professional development opportunities in an inclusive culture.

Matching Summary

Match Score: 85

The role focuses on ensuring Quality Control instruments and computerized systems meet strict GMP/GxP compliance standards.

Skills & Requirements

Must-have

  • Mass Spectrometry qualification
  • FTIR equipment qualification
  • Computer System Validation CSV
  • GMP GxP regulatory compliance
  • URS ERES HLRA documentation

Nice-to-have

  • LIMS experience
  • Chromatography data systems
  • Cross-functional collaboration
  • Vendor management skills
  • Continuous improvement mindset

Key Requirements

  • Bachelor's or Master's degree in Chemistry, Engineering, or related field
  • Experience with Mass Spec and FTIR qualification
  • Strong knowledge of 21 CFR Part 11 and GAMP 5 guidelines

Work Rights

Not specified

Tailored Resume

Cover Letter