QC Qualification Engineer (Contract)

NO DEVIATION PTE. LTD.

Singapore
Mass spectrometry (ms) qualification
Ftir and analytical instrument expertise
Computer system validation (csv)
The role is crucial for ensuring all Quality Control instruments and computerized systems meet compliance standards within GMP/GxP frameworks

Job Summary

  • The role is crucial for ensuring all Quality Control instruments and computerized systems meet compliance standards within GMP/GxP frameworks.
  • Candidates will drive QC equipment qualification processes including URS, ERES, HLRA, Vendor IOQ, In-House IOQ, and PQ execution.
  • The company offers a generous leave policy, comprehensive health coverage, and opportunities for continuous learning in an inclusive culture.

Matching Summary

Match Score: 75

The role is crucial for ensuring all Quality Control instruments and computerized systems meet compliance standards within GMP/GxP frameworks.

Skills & Requirements

Must-have

  • Mass Spectrometry (MS) qualification
  • FTIR and analytical instrument expertise
  • Computer System Validation (CSV)
  • 21 CFR Part 11 and Data Integrity knowledge
  • GAMP 5 guidelines application
  • URS, ERES, HLRA, IOQ, PQ drafting

Nice-to-have

  • LIMS and chromatography data systems experience
  • Cross-functional collaboration skills
  • Strong documentation and troubleshooting abilities
  • Inclusive culture participation
  • Continuous professional development mindset

Key Requirements

  • Bachelor's or Master's degree in Chemistry, Analytical Science, Pharmaceutical Science, or Engineering
  • Experience with laboratory equipment qualification specifically Mass Spec and FTIR
  • Strong knowledge of CSV, 21 CFR Part 11, and GAMP 5
  • Familiarity with GMP, GLP, and regulatory requirements for pharmaceutical laboratories

Work Rights

Not specified

Tailored Resume

Cover Letter