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Compliance Engineer

3 months ago

Dublin, Dublin City, Ireland AbbVie Full time

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X ) , Facebook, Instagram ) , YouTube and LinkedIn.

Job Description

We are currently looking for a QA Specialist – Data Integrity to join our team at the AbbVie North Dublin site for a 12-month Fixed Term Contract. The Data Integrity QA Specialist will work closely with IT, Operations, Maintenance, QA Validation, QA Systems and the QA Department to deliver and maintain compliance of the sites infrastructure information systems. The Data Integrity QA Specialist will be responsible for and will be the site point of contact with the Quality Assurance department for liaising with owners of Global enterprise and Infrastructure systems.

  • Represent the site Quality Assurance department as SME in Data Integrity.
  • Manage and drive data integrity and data governance requirements for all Operational Information and Automation systems across the site including Operations, QC, IT and QA Systems.
  • Lead the Data Integrity remediation activities on the site Data Integrity Quality Plan.
  • Track and provide Data Integrity metrics to Quality Management.
  • Provide feedback to department owners on the status of data governance projects and support stakeholders in the mitigation of DI risks.
  • Be current with regulatory requirements (FDA, HPRA, ANVISA etc.) and process a working knowledge of the documentation lifecycle Management in accordance with and all applicable regulatory requirements.
  • Represent AbbVie in regulatory Audits and Self Inspections.
  • Generate and perform data mapping processes, risk assessments of all GMP documentation systems and criticality assessments in conjunction with QRM.
  • Participate as site Data Integrity SME on AbbVie projects and working groups.
  • Identify data governance gaps and propose solutions.
  • Establish a firm understanding of AbbVie IT infrastructure, assess proposed changes for Data Integrity implications, and recommend infrastructure changes to enhance Data Integrity.
  • Ensure alignment between the local and global data management and controls program efforts.
  • Initiate action reports or deviation reports for any applicable nonconformance.

Qualifications

  • Third level qualification in a Science / Engineering or related discipline with 5 years' experience in the healthcare / pharmaceutical industry. Degree or Masters level.
  • A minimum of 3 years experience in a Quality role.
  • Excellent knowledge of regulatory requirements is essential.

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status. US & Puerto Rico only - to learn more, visit