QA CSV Engineer

ANTER CONSULTING PTE. LTD.

Islandwide, Singapore
Not specified
Cgmp and gamp 5 compliance knowledge
21 cfr part 11 regulatory expertise
Alcoa+ data integrity principles
The QA CSV Engineer position at ANTER CONSULTING PTE. LTD. involves ensuring compliance with quality oversight in computer system validation (CSV) activities, adhering to regulatory standards. The role requires collaboration with various teams to mitigate compliance risks and ensure project integrity

Job Summary

  • The role provides QA oversight for CSV activities to ensure strict adherence to cGMP, GAMP 5, and 21 CFR Part 11 regulations.
  • Candidates will review and approve critical validation deliverables including User Requirements Specifications, risk assessments, and IQ/OQ/PQ protocols.
  • The position requires serving as the QA representative on project teams to identify compliance risks early and maintain project momentum.

Matching Summary

Match Score: 85

The QA CSV Engineer position at ANTER CONSULTING PTE. LTD. involves ensuring compliance with quality oversight in computer system validation (CSV) activities, adhering to regulatory standards. The role requires collaboration with various teams to mitigate compliance risks and ensure project integrity.

Skills & Requirements

Must-have

  • cGMP and GAMP 5 compliance knowledge
  • 21 CFR Part 11 regulatory expertise
  • ALCOA+ data integrity principles
  • IQ/OQ/PQ protocol review skills
  • Risk assessment and validation deliverables

Nice-to-have

  • Strong stakeholder collaboration abilities
  • Experience with system upgrades and replacements
  • Problem-solving in compliance gaps

Key Requirements

  • Knowledge of Annex 11 regulations
  • Experience with change controls and test deviations
  • Ability to interpret requirements for IT and OT teams

Work Rights

Not specified

Tailored Resume

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