In_senior Associate_csv,qms_rc - Internal Audit_advisory_noida

PwC UK

Noida, India
Computer system validation (csv)
Instrument qualification iq oq pq
Gxp compliance fda 21 cfr part 11
The role involves assisting in the planning, execution, and documentation of Computer System Validation activities including risk assessments and qualification protocols

Job Summary

  • The role involves assisting in the planning, execution, and documentation of Computer System Validation activities including risk assessments and qualification protocols.
  • Candidates will collaborate with cross-functional teams such as Quality Assurance, IT, and Manufacturing to ensure systems meet compliance standards.
  • PwC offers a vibrant community focused on trust, innovation, and inclusive benefits designed to help employees thrive in work and life.

Matching Summary

The role involves assisting in the planning, execution, and documentation of Computer System Validation activities including risk assessments and qualification protocols.

Skills & Requirements

Must-have

  • Computer System Validation (CSV)
  • Instrument Qualification IQ OQ PQ
  • GxP compliance FDA 21 CFR Part 11
  • Validation lifecycle documentation
  • Regulated industry experience

Nice-to-have

  • LIMS and MES familiarity
  • Strong attention to detail
  • Cross-functional collaboration skills
  • Analytical thinking abilities
  • Willingness to learn fast-paced environment

Key Requirements

  • 1-3 years experience in CSV or Instrument Qualification
  • Bachelor's degree in Life Sciences, Engineering, or Computer Science
  • Hands-on experience with HPLCs, GCMS, or laboratory equipment
  • Knowledge of FDA 21 CFR Part 11 and EMA Annex 11

Work Rights

Not specified

Tailored Resume

Cover Letter