In_associate_csv_itra_advisory_mumbai

PwC Sweden

**
4-8 years computer system validation experience
Knowledge of gamp5 guideline and gxp regulations
Experience with us fda 21 cfr part 11 compliance
** PwC Sweden is seeking an Associate for their Advisory line of service, focusing on Computer System Validation (CSV), Software Testing, and IT Compliance. The ideal candidate will have 4-8 years of relevant experience and a strong understanding of SDLC methodologies, regulations, and validation processes. **

Job Summary

  • The role focuses on providing end-to-end internal audit services including function setup, transformation, and co-sourcing using AI and risk technology.
  • Candidates must possess 4-8 years of experience in Computer System Validation, Software Testing, and IT Compliance within regulated environments.
  • PwC offers a vibrant community focused on trust, innovation, and distinctive outcomes with inclusive benefits and mentorship programs.

Matching Summary

Match Score: 75

** PwC Sweden is seeking an Associate for their Advisory line of service, focusing on Computer System Validation (CSV), Software Testing, and IT Compliance. The ideal candidate will have 4-8 years of relevant experience and a strong understanding of SDLC methodologies, regulations, and validation processes. **

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 compliance
  • 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
  • Ability to work in a collaborative and inclusive environment

Key Requirements

  • Bachelor of Engineering degree required
  • 4-8 years of relevant work experience
  • Knowledge of Change Control, Deviation Management, CAPA, and Periodic Review

Work Rights

Not specified

Tailored Resume

Cover Letter