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Quality Systems Analyst

AbbvieWestport, MayoFull-timeTemporary
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. Unleashing your full potential? We OFFER that. Rewarding career with ongoing professional development? 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. We take pride in serving and supporting our communities and protecting the environment, making a lasting impact felt within healthcare and beyond. We are now recruiting a Quality Systems Analyst at our Westport Site in Mayo on a 1-year fixed-term contract basis. In your new role, you will join a talented project team as part of the MSTU project to deliver the Windows 10 upgrade on laboratory systems, identifying gaps, planning interim actions and remediations inclusive of evaluating data integrity. So, if you are ready to make a significant impact with your next role and want to be part of an exciting project, read on to find out more and get your application started today! Key activities: Advising project team on related topics including data management and control. Generating and managing non-conformance records in Global TrackWise. Understanding and advising on change control and change management. Managing changes and maintaining existing Laboratory systems in a validated state. Supporting existing quality systems and aiding in the investigation/resolution of issues as they arise. Working on new systems planning phases to include defining processes. Assessing the Risk associated with changes. Partaking in Vendor consultation & functional specification definition. System configuration and supporting re-qualification. Writing and reviewing SOPs, test protocols and reports. Completing user access reviews and delivering training to end-users. Working in a cross-functional capacity between BT and the Laboratories SMEs to ensure planned and unplanned systems downtime does not impact business function. Assisting the Project Manage Team in identifying opportunities for improvement and delivery efficiency. Qualifications Education and Technical Skills: Degree qualified in relevant scientific discipline. Extensive knowledge of laboratory systems, ideally including validation testing, commissioning and decommissioning. Knowledge of computer systems pertinent to role preferred. Proven track record in quality systems configuration/validation implementation OR support. Knowledge of DI and CSV regulatory standards and compliance requirements with an emphasis on European and US regulatory environments. Excellent communication skills. Ability to use sound judgment to make effective decisions within appropriate timeframes. Proven to be self-directed, self-motivated, and able to prioritise competing priorities. So, if all this sound like the right role for you, then apply today! The closing date for the application is the 8th of Oct. 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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