Data Integrity Specialist

1 week ago

Cork, Cork, Ireland beBeeData Full time €90,000 - €120,000

Our organization is seeking a seasoned Data Integrity Specialist with a strong focus on risk-based approaches to data management. This role will involve collaborating with our pharmaceutical client in Cork, working together to ensure the integrity of GxP-regulated systems.

About the Position

This position requires expertise in assessing data integrity risks, implementing mitigation strategies, and ensuring compliance with regulatory expectations.

  • Perform data integrity risk assessments on GxP-critical systems and processes.
  • Define and implement risk-based validation and compliance strategies aligned with DI principles.
  • Support the development of policies, procedures, and technical controls to maintain data accuracy, completeness, consistency, and traceability.
Key Responsibilities

The successful candidate will provide subject matter expertise in data integrity regulations and guidance, partner with IT, QA, and system owners to design and implement effective data lifecycle controls, ensure compliance with 21 CFR Part 11, EU Annex 11, GAMP 5, and relevant industry standards, lead investigations and remediation activities where data integrity gaps are identified, support regulatory inspections and internal audits, and contribute to continuous improvement of the DI compliance framework.

This specialist will have a deep understanding of regulatory requirements for DI and electronic records/e-signatures, as well as experience in Csv within regulated industries, with a strong emphasis on data integrity and risk-based validation.

The ideal candidate will hold a Bachelor's degree in Engineering, Computer Science, Life Sciences, or a related field.

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