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QA Specialist

4 months ago

Dublin, Dublin City, Ireland AbbVie Full time
Job Description

We are looking for a Quality Specialist to join our team in Clonshaugh, Dublin. As part of the Quality Assurance Validation team in Clonshaugh, you will play a key role in maintaining and enhancing the quality oversight and compliance systems for validation activities at the site. Your responsibilities will include supporting day-to-day activities related to cleaning, facilities, and equipment validation, as well as participating in knowledge transfer initiatives to become a Subject Matter Expert in quality assurance for new processes.

If you are interested and want to discover more, keep on reading

Primary duties and responsibilities:
  • Represent the Quality Assurance Department as Subject Matter Expert in compliance,
  • Contribute to SAP and POMs refinement initiatives,
  • Collaborate with Site Operations and BTS functions to ensure compliance,
  • Coordinate compliance activities across Manufacturing, Laboratory, and IT areas,
  • Provide quality metrics to Quality Management when needed,
  • Assess quality risks in GMP documentation systems and assist in risk mitigation,
  • Support site risk management efforts,
  • Participate in building and approving site PQR requirements,
  • Handle site CAPAs, LIRs, and Complaints,
  • Prepare and deliver quarterly Quality Management review,
  • Conduct Internal and External Audits and assist in preparation,
  • Implement Data Integrity Quality Plan for the site,
  • Manage Change review board and associated activities for metric reporting,
  • Onboard and approve suppliers, and manage material release processes,
  • Generate and progress documents through the management system,
  • Stay updated on regulatory requirements,
  • Ensure alignment between local and global procedural requirements,
  • Write, Review, and Approve protocols, reports, and SOPs,
  • Drive process innovation and improvements,
  • Report any deviations to standards to the line manager,
  • Proactively manage action items to prevent delays,
  • Complete all required training for the job role,
  • Assist in training new personnel,
  • Adhere to safety and compliance procedures to promote safety awareness.
Qualifications:
  • Bachelor's degree in Science, Engineering, or related field,
  • 5+ years of industry experience with strong GMP knowledge,
  • 3+ years of quality assurance experience,
  • Familiarity with compliance requirements and regulatory standards,
  • Experience with SAP or ERP systems,
  • Strong communication, problem-solving, and analytical skills,
  • Goal-oriented with a passion for excellence,
  • Proficiency in Microsoft Office Suite.

AbbVie is dedicated to integrity, innovation, community service, and diversity. We are an equal opportunity employer committed to creating a diverse and inclusive workplace.