In_associate_csv_itra_advisory_mumbai

PwC

Mumbai, 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 delivery models.
  • PwC offers a vibrant community focused on trust, innovation, and inclusive benefits that support personal growth and wellbeing.

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
  • LIMS or QMS system experience
  • AI and risk technology delivery models
  • Agile and Waterfall SDLC methodology
  • Collaborative team environment

Key Requirements

  • Bachelor of Technology degree required
  • 4-8 years work experience in CSV and IT Compliance
  • Knowledge of Change Control and CAPA processes

Work Rights

Not specified

Tailored Resume

Cover Letter