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Qualified Person

AbbvieSligoFull-time
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. Great work-life balance? We OFFER that. A rich, innovative pipeline? We OFFER that too. 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 worldwide. 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. At our Manorhamilton Rd. site in Sligo, we have a high-potent commercialization and launch facility for small molecule API and Oral Solid Dose products. It is a young and vibrant site with a strategic product launch facility within the wider AbbVie Operations network. We are now recruiting an experienced Qualified Person to join the team on a 1-year fixed contract basis. As our new Qualified Person (QP), you will be responsible for the management of multiple site projects include batch size increase, optimization of the current commercial process, assurance of supply initiatives, whilst driving quality and project plan related discussions to closure by working with all relevant functional teams and effectively troubleshooting and driving decisions. With an exciting pipeline of products and a great salary and benefits package, this may be the career move you have been waiting for..... In your new role, you will: Support and implement key site strategies/initiatives (batch size increase, optimization of current commercial process, assurance of supply initiatives) on time and within budget Manage multiple projects concurrently, operating with minimal supervision Proactively identify and drive quality and project plan related issues to closure by working with all relevant functional lines and effectively troubleshooting and driving decisions Understand project drivers, requirements, scenarios and options. Proactively drive the development of contingency and/or risk mitigation plans. Manage competing timelines and make difficult decisions regarding priorities among projects. Effectively communicate and present project status to Operations senior management and stakeholders. Maintain and develop knowledge of technical and scientific progress and changes in quality management relevant to the products they are required to certify Actively participate in developing relevant and technical knowledge for new products etc. Ensure all audits have been carried out as required by the quality assurance system Ensuring that new products manufactured at AbbVie Ireland NL B.V. meet applicable regulatory requirements and AbbVie procedures and policies. Ensure products and batches comply with the provisions of the marketing authorisation and per Good Manufacturing Practice, including clinical manufacturing supply. Ensure that any deviations or planned changes in production or quality control have been authorised by the persons responsible for a defined system. Confirm that all necessary checks and tests have been performed, including any additional sampling, inspection, tests or checks initiated because of deviations or planned change. To ensure all necessary production and quality control documentation has been completed and endorsed by the staff authorised. Qualifications Education and Experience Third level qualification in a science discipline with 5 years experience in the healthcare/pharmaceutical industry MSc in Industrial Pharmaceutical Science or a similar course recognized by Regulatory Authority to permit Qualified Person (QP) status as per Article 49 of Directive 2001/83/EC. 5 years of industrial experience gained in an FDA and EMEA approved pharmaceutical environment Strong interpersonal and decision making So, does this all sound like the right role for you? Then 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 Experienced 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.

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