Welcome to AbbVie!

　　We are a global, research-based biopharmaceutical company that combines the focus and passion of leading-edge biotech with the expertise and capability of an established pharmaceutical leader. Redefining what is possible is our business and our passion. Our goal is to help patients live healthier lives and we are proud to be a Great Place to Work.

　　We are recruiting a Quality Specialist (12 months FTC ) to join our diverse team in Clonshaugh, Dublin.

　　Are you intrigued? Do you want to learn more?

　　Co-ordinate compliance activities for all systems for Manufacturing, Laboratory, and IT areas,

　　Track and provide relevant quality metrics to Quality Management as required,

　　Perform quality risk assessment of all GMP documentation systems and support stakeholders in the mitigation of compliance risks,

　　Support the Site Risk management efforts,

　　Heavily involved in the coordination, building and approval of the site PQR requirements,

　　Write, Review or Approve site CAPAs, LIRs and Complaints, Change Controls,

　　Compile and Deliver quarterly Quality Management review for AbbVie North Dublin,

　　Conduct Internal and External Audits and support preparation,

　　Support Data Integrity activities for the site, if required,

　　Management of the Change review board and associated activities around metric reporting for changes across the site,

　　Complete Supplier onboarding and approval, and material release from said suppliers in conjunction with appropriate above site global functions,

　　Write, Review or Approve Quality Agreements with suppliers, service providers etc.,

　　Generation and progression of documents managed through the document management system and generation of metrics, to be reported as part of management review. Prioritize risks and workload to ensure the dept and wider functions metrics are met from a documentation and system compliance perspective,

　　Be current with regulatory requirements,

　　Ensure alignment between the local and global procedural requirements and QRM initiatives,

　　Write, Review and Approve protocols, reports and SOP’s to effect compliance gap remediation as appropriate,

　　Seek and deliver on process innovation and continuous process improvements,

　　Recognize and report to immediate line manager any issues, or deviations from accepted standards and metrics,

　　Proactive escalation for potential events that may impact compliance or metrics to line manager,

　　Proactive management of action items in advance of their due date to prevent delays and approval on time in accordance with site and system metrics,

　　Complete and conform to all training requirements for job role, including company-required and job role-specific training,

　　Carry out and assist in the ongoing training of new and existing personnel, as appropriate,

　　Observe all safety and compliance procedures by participating in Safety and Compliance Walks and actively highlight any safety / Compliance concerns to help drive the reduction of accidents / near misses or Compliance gaps.

　　So, what do you need to do this role?

　　A third level qualification in Science, Engineering or related discipline, preferably a Bachelor’s degree.

　　Relevant industry experience (5+ years preferred) including strong knowledge in GMP regulations working in a pharmaceutical, biotechnology or medical device industry,

　　3+ years of experience in a quality assurance role,

　　Experience in compliance requirements including Eudralex, 21 CFR Parts 210, 211, ICH Q9, Q10 and other applicable regulatory requirements,

　　SAP or ERP system experience,

　　Excellent communication and interpersonal skills, including technical writing,

　　Strong analytical and problem-solving skills,

　　Maintain credibility and integrity,

　　Goal focused,

　　Demonstrate passion and energy,

　　Basic Microsoft Office Suite skills .

　　It’s important to remember, AbbVie is an Equal Employment Opportunity Employer; we value bringing together individuals from diverse backgrounds to develop innovative solutions for patients and being part of an inclusive work environment .

　　AbbVie 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.