CSV Consultant

ORKA CONSULTING PARTNERS PTE. LTD.

Singapore
Computer system validation experience
Gamp5 regulatory knowledge
21 cfr part 11 compliance
The role involves delivering CSV consulting projects to support the implementation of computerized systems in Life Sciences clients while ensuring GxP compliance

Job Summary

  • The role involves delivering CSV consulting projects to support the implementation of computerized systems in Life Sciences clients while ensuring GxP compliance.
  • Candidates will draft and maintain critical validation documents such as URS, Risk Assessments, and IOPQ Protocols across the system lifecycle.
  • The company offers a professional environment with impactful learning opportunities, mentoring from experienced professionals, and access to extensive training materials.

Matching Summary

Match Score: 75

The role involves delivering CSV consulting projects to support the implementation of computerized systems in Life Sciences clients while ensuring GxP compliance.

Skills & Requirements

Must-have

  • Computer System Validation experience
  • GAMP5 regulatory knowledge
  • 21 CFR Part 11 compliance
  • DeltaV or Siemens PCS7 systems
  • Validation documentation drafting

Nice-to-have

  • Change incident problem management
  • Cross-functional stakeholder management
  • Independent work delivery style
  • Windows 11 upgrade projects
  • Strong learning attitude culture

Key Requirements

  • Bachelor's degree in Life Sciences or Engineering
  • 2-4 years of CSV or automation experience
  • Experience leading validation projects from planning to reporting

Work Rights

Not specified

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