Bsa/ Validation - Instrument Software

Thermo Fisher Scientific UK

Hybrid (office and potential remote work)
Ema regulatory guidelines knowledge
System development lifecycle (sdlc) experience
Clinical trials operational processes understanding
Thermo Fisher Scientific is seeking a BSA/Validation professional for their global team focused on validating lab instrumentation in compliance with European Medicines Agency guidelines. The role involves managing system validation tasks, collaborating across departments, and ensuring effective project communication

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 requires creating system validation test cases, performing risk assessments, and participating in client and regulatory inspections.
  • Thermo Fisher Scientific offers resources to achieve individual career goals while enabling customers to make the world healthier through life-changing therapies.

Matching Summary

Match Score: 85

Thermo Fisher Scientific is seeking a BSA/Validation professional for their global team focused on validating lab instrumentation in compliance with European Medicines Agency guidelines. The role involves managing system validation tasks, collaborating across departments, and ensuring effective project communication.

Skills & Requirements

Must-have

  • EMA regulatory guidelines knowledge
  • System development lifecycle (SDLC) experience
  • Clinical trials operational processes understanding
  • System risk assessment execution
  • Validation test case creation

Nice-to-have

  • Strong problem-solving and analytical skills
  • Effective vendor communication abilities
  • Experience with client regulatory inspections
  • Project timeline management skills

Key Requirements

  • Bachelor's degree or equivalent qualification
  • Familiarity with EMA and other regulatory guidelines
  • Solid understanding of software development life cycle

Work Rights

Not specified

Tailored Resume

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