In_associate_csv_itra_advisory_mumbai

263

Mumbai, India
4-8 years work experience in csv
Knowledge of gamp5 guideline and gxp
Experience with us fda 21 cfr part 11
The role focuses on providing end-to-end internal audit services including IA function setup, transformation, and co-sourcing

Job Summary

  • The role focuses on providing end-to-end internal audit services including IA function setup, transformation, and co-sourcing.
  • Candidates will leverage knowledge of regulations like EU Annex 11 and ALCOA+ principles to address the full spectrum of risks.
  • PwC offers a vibrant community with inclusive benefits, flexibility programmes, and mentorship to help employees thrive.

Matching Summary

The role focuses on providing end-to-end internal audit services including IA function setup, transformation, and co-sourcing.

Skills & Requirements

Must-have

  • 4-8 years work experience in CSV
  • Knowledge of GAMP5 Guideline and GxP
  • Experience with US FDA 21 CFR Part 11
  • Proficiency in manual testing methodologies
  • Authoring validation deliverables like VP and URS

Nice-to-have

  • Exposure to Valgenesis tools
  • Experience with LIMS or QMS systems
  • Knowledge of AI and risk technology
  • Familiarity with Agile and Waterfall models

Key Requirements

  • Bachelor of Engineering degree required
  • 4-8 years of professional experience
  • B.Pharm qualification preferred

Work Rights

Not specified

Tailored Resume

Cover Letter