In_associate_csv,qms_rc - Internal Audit_advisory_noida

263

Noida, India
Not specified (assumed to be hybrid based on industry standards).
Computer system validation (csv)
Instrument qualification iq oq pq
Gxp compliance fda 21 cfr part 11
PwC is seeking a detail-oriented Associate for their Internal Audit Advisory team in Noida, India, specializing in Computer System Validation (CSV) within regulated industries such as pharmaceuticals and biotech. The role involves assisting with validation activities to ensure compliance and functionality of computer systems and laboratory instruments

Job Summary

  • This role involves supporting validation activities to ensure computer systems and laboratory instruments meet compliance standards.
  • The ideal candidate will have a foundational understanding of Computer System Validation within regulated pharmaceutical or biotech environments.
  • Candidates will collaborate with cross-functional teams including Quality Assurance, IT, and Manufacturing to ensure operational requirements are met.

Matching Summary

Match Score: 85

PwC is seeking a detail-oriented Associate for their Internal Audit Advisory team in Noida, India, specializing in Computer System Validation (CSV) within regulated industries such as pharmaceuticals and biotech. The role involves assisting with validation activities to ensure compliance and functionality of computer systems and laboratory instruments.

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
  • Willingness to learn in fast-paced environment

Key Requirements

  • Bachelor of Technology degree
  • 1-3 years experience in CSV
  • Experience with HPLC or GCMS qualification
  • Knowledge of EMA Annex 11

Work Rights

Not specified

Tailored Resume

Cover Letter