In_senior Associate_csv_itra_advisory_mumbai

PwC Sweden

Not specified
4-8 years computer system validation experience
Knowledge of gamp5 guideline and gxp regulations
Experience with us fda 21 cfr part 11 and eu annex 11
PwC Sweden is seeking a Senior Associate for its advisory services in Mumbai, focusing on internal audit and compliance related to Computer System Validation (CSV). The ideal candidate should have 4-8 years of experience in CSV, software testing, and IT compliance, with a strong understanding of relevant regulatory guidelines

Job Summary

  • The role focuses on providing independent assessments of financial statements and internal controls while evaluating compliance with regulations.
  • Candidates will be responsible for authoring key Computer System Validation deliverables including User Requirement Specifications and Validation Summary Reports.
  • PwC offers a vibrant community environment that rewards contributions, supports wellbeing, and provides inclusive benefits and mentorship.

Matching Summary

Match Score: 85

PwC Sweden is seeking a Senior Associate for its advisory services in Mumbai, focusing on internal audit and compliance related to Computer System Validation (CSV). The ideal candidate should have 4-8 years of experience in CSV, software testing, and IT compliance, with a strong understanding of relevant regulatory guidelines.

Skills & Requirements

Must-have

  • 4-8 years Computer System Validation experience
  • Knowledge of GAMP5 Guideline and GxP regulations
  • Experience with US FDA 21 CFR Part 11 and EU Annex 11
  • Proficiency in SDLC, STLC, Waterfall, Agile, and V model
  • Manual testing skills including regression and smoke testing
  • Authoring validation deliverables like URS, VP, IQ/OQ/PQ

Nice-to-have

  • Exposure to CSV tools such as Valgenesis
  • Experience with LIMS or QMS systems
  • Knowledge of AI and risk technology delivery models
  • Familiarity with cyber, forensics, and compliance areas

Key Requirements

  • Bachelor of Engineering degree required
  • 4-8 years of work experience in CSV and IT Compliance
  • Bachelor of Pharmacy preferred

Work Rights

Not specified

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