In_associate_csv_itra_advisory_mumbai

UNYCC

Not specified; not specified; not specified
4-8 years computer system validation experience
Gamp5 guideline and gxp knowledge
Us fda 21 cfr part 11 compliance
The role focuses on providing independent assessments of financial statements, internal controls, and risk management processes to enhance credibility for stakeholders

Job Summary

  • The role focuses on providing independent assessments of financial statements, internal controls, and risk management processes to enhance credibility for stakeholders.
  • Candidates will be responsible for authoring critical validation deliverables including User Requirement Specifications, Functional Risk Assessments, and IQ/OQ/PQ protocols.
  • The position offers the opportunity to work within a vibrant community of solvers that leads with trust and creates distinctive outcomes using innovative technology.

Matching Summary

The role focuses on providing independent assessments of financial statements, internal controls, and risk management processes to enhance credibility for stakeholders.

Salary

Not specified; Not specified; Not specified

Skills & Requirements

Must-have

  • 4-8 years Computer System Validation experience
  • GAMP5 Guideline and GxP knowledge
  • US FDA 21 CFR Part 11 compliance
  • Manual testing and defect tracking
  • Validation deliverable authoring

Nice-to-have

  • Exposure to Valgenesis CSV tools
  • LIMS or QMS system experience
  • AI and risk technology delivery models
  • Agile and Waterfall SDLC methodology
  • Cyber and forensics expertise

Key Requirements

  • Bachelor of Technology degree required
  • 4-8 years of relevant work experience
  • No government clearance required
  • Not available for work visa sponsorship

Work Rights

Not specified

Tailored Resume

Cover Letter