Clinical Auditing Specialist Ii - Vendor And Information System Audits

PPD (Thermo Fisher) UK

Gxp regulatory compliance knowledge
Computerized system lifecycle management
21 cfr part 11 expertise
The role involves conducting and leading internal information systems audits to ensure regulatory compliance and quality standards in clinical trials

Job Summary

  • The role involves conducting and leading internal information systems audits to ensure regulatory compliance and quality standards in clinical trials.
  • Candidates will serve as a knowledgeable resource for operational departments regarding audit and quality assurance subject matters.
  • Joining Thermo Fisher Scientific offers the opportunity to work within a global team that values passion, innovation, and scientific excellence.

Matching Summary

The role involves conducting and leading internal information systems audits to ensure regulatory compliance and quality standards in clinical trials.

Skills & Requirements

Must-have

  • GxP regulatory compliance knowledge
  • Computerized system lifecycle management
  • 21 CFR Part 11 expertise
  • Root cause analysis skills
  • Internal audit execution experience

Nice-to-have

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

Key Requirements

  • Bachelor's degree or equivalent qualification
  • 2+ years of QA experience required
  • Valid driver's license required
  • Familiarity with GAMP 5 R2 guidelines
  • Experience with software development lifecycle (SDLC)

Work Rights

Not specified

Tailored Resume

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