About AbbVie AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. A career of limitless possibility? We OFFER that too. Challenging work with a global impact? We OFFER that. Welcome to AbbVie! At AbbVie, we offer you the resources and a global reach to empower your innovative mindset. From day one, we’ve known it takes teamwork and collaboration to develop the scientific breakthroughs, innovative pipelines, and therapies that change millions of patients’ lives around the world. In short, we know it takes “you” to make those ground-breaking advancements happen. We take pride in serving and supporting our communities and protecting the environment, making a lasting impact that's felt within healthcare and beyond. We are now recruiting a Compliance Specialist-QA on a contract basis to join our diverse Quality Control team in Clonshaugh, Dublin. The Compliance Specialist-QA is responsible for the co-ordination and oversight of activities required to maintain and improve compliance at the AbbVie Clonshaugh Site. The Compliance Specialist will be responsible for risk assessing and enhancing quality management systems, data management and control systems at the manufacturing site. The incumbent supports systems such as TrackWise Deviations (non-conformances), CAPAs, Change Control, SAP/POMS, Documentation management systems and other software applications, as needed. .Is this a team you want to be part of? Then read on……..(please delete as appropriate) Key Responsibilities: Represent the site Quality Assurance department as SME in compliance Manage/input into SAP/POMs refinement initiatives. Liaise with Site BTS and Operations functions as necessary to support compliance initiatives Co-ordinate compliance activities for all systems for Manufacturing, Laboratory, Manufacturing 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. Prioritize risks and work with all site departments to ensure documentation and system compliance Be current with regulatory requirements (FDA, HPRA) and possess a working knowledge of the documentation lifecycle Management in accordance with 21CFR Parts 210, 211, 11/ Annex 11, ICH Q9,Q10, GAMP5 and all applicable regulatory requirements Ensure alignment between the local and global compliance and QRM initiatives Assure all systems, processes and their outcomes comply with standards that meet applicable international and national regulations and guidelines and fulfill AbbVie’s requirements Write or review and approve protocols, reports and SOP’s to effect compliance gap remediation as appropriate Initiate action reports or deviation reports for any applicable nonconformance Seek process innovation and continuous process improvements Recognize and report to immediate supervisor any issues or deviations from accepted standards Provide status updates on own activities and productivity challenges according to defined procedures 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 and actively highlight any safety concerns to help drive the reduction of accidents or near misses Qualifications Qualifications: A third level qualification in Science, Engineering or related discipline, preferably a bachelor’s degree Relevant industry experience (5+ years) 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 for validating IT systems in accordance with regulatory Data Integrity controls including 21CFR Parts 210, 211, 11/ Annex 11, ICH Q9, Q10, GAMP5 and all 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 So, does this all sound like the right role for you? Then come join Abbvie! 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. Travel No Job Type Temporary Work Schedule Full-time Job Level Code IC Equal Employment Opportunity At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.