Clinical Auditing Specialist Ii - Vendor And Information System Audits

Thermo Fisher Scientific UK

Gxp regulatory compliance knowledge
21 cfr part 11 expertise
Computer system validation concepts
The role involves conducting and leading internal information systems audits for clinical trials and data integrity

Job Summary

  • The role involves conducting and leading internal information systems audits for clinical trials and data integrity.
  • Candidates will provide GxP consultation regarding 21 CFR Part 11 and EMA guidelines for computerized systems.
  • Join a global team that values passion, innovation, and scientific excellence while contributing to breakthroughs.

Matching Summary

The role involves conducting and leading internal information systems audits for clinical trials and data integrity.

Skills & Requirements

Must-have

  • GxP regulatory compliance knowledge
  • 21 CFR Part 11 expertise
  • Computer system validation concepts
  • Internal audit leadership experience
  • Root cause analysis skills

Nice-to-have

  • Strong negotiation and conflict management
  • Ability to work under stress
  • Flexible multi-tasking capabilities
  • Excellent oral and written communication

Key Requirements

  • Bachelor's degree or equivalent
  • 2+ years of QA experience
  • Valid driver's license
  • Corporate credit card qualification

Work Rights

Not specified

Tailored Resume

Cover Letter