In-senior Associate_csv_itra_advisory_mumbai

PwC PricewaterhouseCoopers GmbH

Mumbai, India
4-8 years computer system validation experience
Knowledge of gamp5 guideline and gxp regulations
Experience with sdlc and stlc methodologies
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 using AI and advanced 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 other assurable information to enhance credibility for stakeholders.

Skills & Requirements

Must-have

  • 4-8 years Computer System Validation experience
  • Knowledge of GAMP5 Guideline and GxP regulations
  • Experience with SDLC and STLC methodologies
  • Manual testing including regression and smoke testing
  • Authoring validation deliverables like URS and IQ/OQ/PQ

Nice-to-have

  • Exposure to CSV tools such as Valgenesis
  • Knowledge of LIMS/QMS systems
  • Familiarity with AI and risk technology delivery models
  • Experience in cyber, forensics, and compliance areas
  • Ability to work in a collaborative team environment

Key Requirements

  • Bachelor of Engineering degree required
  • 4-8 years of work experience in CSV and IT Compliance
  • Mandatory knowledge of US FDA 21 CFR Part 11 and EU Annex 11

Work Rights

Not specified

Tailored Resume

Cover Letter