Senior Quality Assurance Specialist

3 days ago


Abingdon, Oxfordshire, United Kingdom MaxAd Fixed Fee Recruitment Full time

**Job Summary:**

We are seeking an experienced IT Quality professional to join our client's innovative IT team on a 9-month fixed term contract basis.

The successful applicant will play a crucial role in ensuring high standards of data quality, security, and compliance across our client's IT systems, particularly those supporting scientific, clinical, and regulatory functions.

About the Role:

  • Implement and maintain IT quality control processes to ensure compliance with GxP, 21 CFR Part 11, and other regulatory requirements in IT systems.
  • Regularly audit data quality for scientific and clinical trial data, identifying issues and collaborating with stakeholders to ensure high accuracy and reliability.
  • Collaborate on IT and data projects to embed quality standards and ensure all deliverables meet compliance requirements.
  • Create and maintain quality documentation, including SOPs and policies, and report on data quality metrics and system compliance.

Requirements:

  • Bachelor's degree or equivalent experience in Computer Science, Information Technology, Data Science, or a related field.
  • 3+ years in IT quality assurance, computer systems validation, data quality, or regulatory compliance, preferably within life sciences, pharmaceutical, or biotech industries.
  • Technical Skills: Proficiency in data management and quality tools, knowledge of GxP, Part 11 compliance, CSV according to GAMP principles, experience of ISO27001 and SOC frameworks would be an advantage.

Estimated Salary Range: £45,000 - £55,000 per annum, plus benefits.



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