In_senior Associate_csv_itra_advisory_hyderabad

Pwpoland

Computer system validation (csv)
Software testing life cycle (stlc)
Manual testing and defect tracking
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)
  • Manual Testing and Defect Tracking
  • Knowledge of GAMP5 Guideline and GxP
  • Experience with SDLC methodologies
  • Authoring CSV deliverables

Nice-to-have

  • Exposure to CSV tools such as Valgenesis
  • Knowledge of Change Control and CAPA
  • Experience with Agile and Waterfall models
  • Embracing Change
  • Data Analysis and Interpretation
  • Communication
  • Compliance Auditing

Key Requirements

  • 4-8 years experience in CSV and IT Compliance
  • B.Tech/B.Pharm/M.Pharm degree
  • Knowledge of US FDA 21 CFR Part 11 and EU Annex 11
  • Experience authoring Validation Plan and related documents
  • Not available for work visa sponsorship

Work Rights

Not specified

Tailored Resume

Cover Letter