System Validation Specialist

7 days ago

London, Greater London, United Kingdom Calibre Global Consulting Full time
Computerized System Validation Tester

At Calibre Global Consulting, we are seeking a skilled Computerized System Validation Tester to join our team. As a CSV Tester, you will play a crucial role in ensuring that computerized systems in the pharmaceutical, biotech, or medical device industries meet regulatory standards and function correctly.

Key Responsibilities:
  • Develop and execute test plans for computerized systems to ensure compliance with industry regulations.
  • Identify potential risks and ensure that systems meet regulatory requirements.
  • Document test results and any issues found, providing detailed analysis and recommendations for improvement.
  • Collaborate with Quality Assurance and IT teams to address any problems or concerns.
Requirements:
  • Bachelor's degree in a related field, such as computer science, engineering, or a life science.
  • Proven experience in CSV within the pharmaceutical, biotech, or medical device industries.
  • Strong knowledge of industry regulations, including GxP and FDA guidelines.
  • Excellent attention to detail and effective communication skills.
  • Experience with automated testing tools and risk management methodologies.
  • Knowledge of data integrity and compliance standards.
  • Certifications such as Certified Tester (ISTQB) or similar are a plus.

We are open to both permanent and contract positions, and the role is remote working. You must be based in the UK or Ireland to be considered for this opportunity.

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