In_senior 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 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 be part of a vibrant community of solvers that leads with trust and creates distinctive outcomes for clients using technology-driven innovation.
  • The position requires authoring critical validation deliverables such as User Requirement Specifications, Functional Risk Assessments, and Validation Summary Reports.

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 work experience in CSV
  • Knowledge of GAMP5 Guideline and GxP
  • Experience with US FDA 21 CFR Part 11
  • Authoring Validation deliverables like URS and VP
  • Manual testing including Regression and Smoke testing

Nice-to-have

  • Exposure to Valgenesis tools
  • Knowledge of LIMS/QMS systems
  • Familiarity with Agile and Waterfall SDLC models
  • Understanding of AI and risk technology delivery models
  • Experience with Change Control and CAPA processes

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter