Bsa/ Validation - Instrument Software

PPD (Thermo Fisher)

UK
**
Ema regulatory guideline knowledge
System validation test case creation
Software development life cycle understanding
** Thermo Fisher Scientific is seeking a BSA/Validation professional to join their global team in the UK, focusing on validating lab instrumentation according to EMA guidelines. The role involves system development lifecycle deliverables and collaboration with various departments to ensure project success. **

Job Summary

  • This role is part of a small global team focused on validating lab instrumentation in accordance with European Medicines Agency guidelines.
  • The position involves creating system validation test cases, performing risk assessments, and participating in client and regulatory inspections.
  • Candidates must possess a solid understanding of clinical trials operational processes and the software development life cycle to ensure quality and accuracy.

Matching Summary

Match Score: 75

** Thermo Fisher Scientific is seeking a BSA/Validation professional to join their global team in the UK, focusing on validating lab instrumentation according to EMA guidelines. The role involves system development lifecycle deliverables and collaboration with various departments to ensure project success. **

Skills & Requirements

Must-have

  • EMA regulatory guideline knowledge
  • System validation test case creation
  • Software development life cycle understanding
  • System risk assessment execution
  • Clinical trials operational processes

Nice-to-have

  • Strong problem-solving analytical skills
  • Effective client communication abilities
  • Vendor management experience
  • Project timeline estimation skills

Key Requirements

  • Bachelor's degree or equivalent qualification
  • Familiarity with EMA and other regulatory guidelines
  • Previous experience in system validation or SDLC

Work Rights

Not specified

Tailored Resume

Cover Letter