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Quality Assurance Specialist

1 month ago

Dartford, Kent, United Kingdom DiaSorin Full time

As a Quality Assurance Specialist with expertise in validation, you will be responsible for leading and coordinating the Site Validation Review Board at DiaSorin. This role involves overseeing the implementation of the S-VMP and managing and supporting validation activities for new and existing site validations.

About the Role

This is a key position that requires strong organizational and time management skills to ensure seamless execution of validation protocols and reports. You will also be responsible for validating and verifying analytical and testing methods, as well as conducting spreadsheet validation for data handling and analysis.

Key Responsibilities
  • Leading and coordinating the Site Validation Review Board
  • Overseeing the implementation of the S-VMP
  • Process Validation: developing, executing, and maintaining validation protocols and reports
  • Test Method Validation: validating and verifying analytical and testing methods
  • Spreadsheet Validation: conducting validation of spreadsheets used for data handling and analysis
  • Contributing to project cross-functional teams as a validation subject matter expert

The ideal candidate should have a strong background in validation processes, quality systems, risk management, and regulatory compliance within the medical device or IVD sector. IVDD/IVDR compliance knowledge is advantageous. Familiarity with risk management principles and practices in a regulated environment is a must.

Requirements

To succeed in this role, you will need:

  • A strong background in validation processes, quality systems, risk management, and regulatory compliance within the medical device or IVD sector
  • IVDD/IVDR compliance knowledge is advantageous
  • Familiarity with risk management principles and practices in a regulated environment is a must
  • Strong organizational and time management skills
What We Offer

We offer a competitive salary of $110,000 per annum, along with a comprehensive benefits package, including health insurance, retirement savings plan, and paid time off. If you are a motivated and experienced professional looking to take your career to the next level, we encourage you to apply.