In_senior Associate_csv_itra_advisory_hyderabad

Dc404

Computer system validation (csv)
Software testing life cycle (stlc)
Knowledge of gamp5 guideline and gxp
At PwC, our people in audit and assurance focus on providing independent and objective assessments of financial statements, internal controls, and other assurable information enhancing the credibility and reliability of this information with a variety of stakeholders

Job Summary

  • At PwC, our people in audit and assurance focus on providing independent and objective assessments of financial statements, internal controls, and other assurable information enhancing the credibility and reliability of this information with a variety of stakeholders.
  • Those in internal audit at PwC help build, optimise and deliver end-to-end internal audit services to clients in all industries, using AI and other risk technology and delivery models.
  • At PwC, we reward your contributions, support your wellbeing, and offer inclusive benefits, flexibility programmes and mentorship that will help you thrive in work and life.

Matching Summary

At PwC, our people in audit and assurance focus on providing independent and objective assessments of financial statements, internal controls, and other assurable information enhancing the credibility and reliability of this information with a variety of stakeholders.

Skills & Requirements

Must-have

  • Computer System Validation (CSV)
  • Software Testing Life Cycle (STLC)
  • Knowledge of GAMP5 Guideline and GxP
  • Manual Testing and Defect Tracking
  • Experience with SDLC methodologies
  • Authoring CSV deliverables

Nice-to-have

  • Exposure to CSV tools such as Valgenesis
  • Knowledge of Change Control and CAPA
  • Embracing Change
  • Analytical Thinking
  • Communication
  • Compliance Auditing
  • Data Analysis and Interpretation

Key Requirements

  • 4-8 years work experience
  • B.Tech/B.Pharm/M.Pharm degree
  • Knowledge of US FDA 21 CFR Part 11 and EU Annex 11
  • Experience with SDLC methodologies including Waterfall and Agile
  • Authoring CSV deliverables like Validation Plan and URS

Work Rights

Not specified

Tailored Resume

Cover Letter