In-senior Associate_csv_itra_advisory_mumbai

Dc404

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 other assurable information to enhance credibility for stakeholders

Job Summary

  • The role involves providing independent assessments of financial statements, internal controls, and other assurable information to enhance credibility for stakeholders.
  • Candidates will help build, optimize, and deliver end-to-end internal audit services including IA function setup, transformation, and managed services.
  • PwC offers a vibrant community focused on trust, innovation, and inclusive benefits with mentorship programs to support personal and professional growth.

Matching Summary

The role involves providing independent assessments of financial statements, internal controls, and other assurable information 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 skills

Nice-to-have

  • Exposure to Valgenesis CSV tools
  • LIMS or QMS system experience
  • Agile and Waterfall SDLC methodology
  • AI and risk technology delivery models
  • Collaborative team environment

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter