System Validation Specialist

4 days ago


London, Greater London, United Kingdom Calibre Global Consulting Full time

Computerized System Validation (CSV) Tester

Location: Remote Working

Industry: Pharmaceuticals, Biotechnology, Medical Devices

We are seeking a skilled Computerized System Validation (CSV) Tester to join our team at Calibre Global Consulting. 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.

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 reports to stakeholders.
  • 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.
  • Experience in CSV within the pharmaceutical, biotech, or medical device industries.
  • Knowledge of industry regulations, including GxP and FDA guidelines.
  • Strong attention to detail and excellent 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.

Please note that we are open to both permanent and contract positions, and the role is remote working. However, you must be based in the UK or Ireland.



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