Quality Lab Validation (CSV)

ANTER CONSULTING PTE. LTD.

Islandwide, Singapore
Csv deliverables including validation plans
Iq/oq documentation execution and review
Traceability matrices and summary reports
The role involves supporting validation and decommissioning activities for GMP laboratory systems and equipment

Job Summary

  • The role involves supporting validation and decommissioning activities for GMP laboratory systems and equipment.
  • Candidates must execute and review critical CSV deliverables such as Validation Plans, Risk Assessments, and Traceability Matrices.
  • The position requires ensuring strict compliance with GxP, 21 CFR Part 11, and Annex 11 regulations while working with cross-functional stakeholders.

Matching Summary

Match Score: 85

The role involves supporting validation and decommissioning activities for GMP laboratory systems and equipment.

Skills & Requirements

Must-have

  • CSV deliverables including Validation Plans
  • IQ/OQ documentation execution and review
  • Traceability Matrices and Summary Reports
  • 21 CFR Part 11 compliance knowledge
  • Annex 11 regulatory adherence

Nice-to-have

  • Experience with system retirement impact assessment
  • Collaboration with QA, IT, and Engineering teams
  • Support for change controls and CAPA activities

Key Requirements

  • Knowledge of GxP and 21 CFR Part 11
  • Experience with IQ/OQ documentation
  • Understanding of data integrity requirements

Work Rights

Not specified

Tailored Resume

Cover Letter