In_senior Associate_itgc_rc - Internal Audit_advisory_noida

PwC

Noida, India
Computer system validation (csv)
Quality management systems (qms)
Gxp compliance requirements
The role involves conducting IT audits and assessments within regulated industries such as pharmaceuticals and biotech

Job Summary

  • The role involves conducting IT audits and assessments within regulated industries such as pharmaceuticals and biotech.
  • Candidates will be responsible for interpreting technical documents, SOPs, and regulatory guidelines to ensure compliance.
  • The position offers the opportunity to work in a vibrant community that values trust, innovation, and inclusive benefits.

Matching Summary

The role involves conducting IT audits and assessments within regulated industries such as pharmaceuticals and biotech.

Skills & Requirements

Must-have

  • Computer System Validation (CSV)
  • Quality Management Systems (QMS)
  • GxP compliance requirements
  • FDA 21 CFR Part 11
  • Validation lifecycle documentation
  • Instrument qualification experience

Nice-to-have

  • Strong attention to detail
  • Excellent communication skills
  • Ability to manage multiple tasks
  • Willingness to learn and adapt
  • Experience with LIMS and MES

Key Requirements

  • Bachelor of Technology degree
  • 1-3 years experience in CSV or Instrument Qualification
  • Knowledge of FDA 21 CFR Part 11 and EMA Annex 11
  • Experience with User Requirements Specification and Test Protocols

Work Rights

Not specified

Tailored Resume

Cover Letter