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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.
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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
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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.
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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