QA Specialist

QA Specialist

AbbVie

Dublin, Ireland

Job Description

The Quality Systems Specialist at AbbVie will support the Global Commercial Distribution and Quality (CDQ) Project Management Office and the CDQ Compliance department by maintaining and improving the quality management system (QMS) to ensure compliance with regulatory requirements and industry standards.

This role involves both managing quality processes, documentation, and systems within the CDQ Compliance Department and Global CDQ PMO.

Primary duties and responsibilities of the position are as follows; other duties may be assigned.

Assist in the Management of the CDQ Project Management Office:

• Prepare, facilitate, and follow up on monthly and on-demand Project Review Board (PRB) meetings.
• Assist in the continuous improvement the PMO process according to Commercial Distribution Quality needs and business priorities.

Monitor Project Progress:

• Ensure alignment of projects with CDQ long-term goals.
• Track and report on project milestones and deliverables.

Develop Project Plans:

• Assist in the creation of project plans, timelines, and budgets for CDQ projects when required.
• Collaborate with stakeholders to ensure project objectives are met.

Conduct Gap Analyses:

• Identify gaps in quality processes and implement corrective actions.
• Participate in continuous improvement initiatives.

Training and Compliance:

• Ensure all employees within the CDQ Compliance Department and Global CDQ PMO are trained and compliant with quality standards.
• Develop and deliver training programs related to quality systems and regulatory requirements.

Quality Systems Analytics:

• Analyse and resolve quality system issues.
• Provide insights and identify areas for improvement within the CDQ Compliance Department and Global CDQ PMO.

Qualifications

• Bachelor’s degree in engineering, Science or related technical/scientific field
• Minimum of 3 years of experience in quality systems within the pharmaceutical industry
• Experience in a GMP environment and Document Control Systems
• Familiarity with regulatory requirements (e.g., ISO 13485, FDA, EU GMP, HPRA

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