QA Specialist - Data Integrity

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.

Requirements

• 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.
• Preferred experience in data integrity or manufacting/QC equipment knowledge.
• Excellent knowledge of regulatory requirements is essential.