In-senior Associate_csv_itra_advisory_bangalore

PwC PricewaterhouseCoopers GmbH

Bangalore, India
4-8 years computer system validation experience
Gamp5 guideline and gxp knowledge
Us fda 21 cfr part 11 compliance
The role involves providing independent assessments of financial statements, internal controls, and risk management processes to enhance credibility for stakeholders

Job Summary

  • The role involves providing independent assessments of financial statements, internal controls, and risk management processes to enhance credibility for stakeholders.
  • Candidates will help build and optimize end-to-end internal audit services using AI and other risk technology to protect organizational value.
  • PwC offers a vibrant community focused on trust, innovation, and inclusive benefits including mentorship and flexibility programs.

Matching Summary

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

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
  • Experience with LIMS or QMS systems
  • Knowledge of Agile and Waterfall models
  • FMEA based Functional Risk Assessment
  • AI and risk technology delivery models

Key Requirements

  • Bachelor of Technology degree required
  • 4-8 years of work experience in CSV
  • Knowledge of SDLC and STLC methodologies

Work Rights

Not specified

Tailored Resume

Cover Letter