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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 Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Quality Systems Analyst

Westport, Connaught, Ireland Req ID 2210732 Category Quality Assurance Division AbbVie

Unleashing your full potential? We OFFER that.
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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 short term fixed contract basis.
In your new role, you will an integral member of the Data Management Team, responsible for the management of laboratory information 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 team, read on to find out more and get your application started today!

A snapshot of your key responsibilities would be:

•    Monitoring Data Integrity for the Laboratory Systems, ensuring robust controls
•    Liaising with SME’s and instrument Admin’s in each of the laboratories concerning DI actions and remediations.
•    Implementing processes for data management and controls.
•    Generating and managing CAPA/change control records in Global TrackWise.
•    Managing changes and maintaining existing LIMS systems in a validated state.
•    Updating the Part Number Table in iLabLIMS as required.
•    Liaising with Global QMS & QRM with configuration updates to product specifications on iLabLIMS.
•    Approval of SAP/LIMS updates as required.
•    Supporting existing quality systems and aiding in the investigation / resolution of issues as they arise.
•    Supporting the new management systems throughout the planning project phases.
•    Defining AS IS, TO BE processes for new projects.
•    Assessing the Risk associated with changes to the current LIMs data management systems (iLabLIMS, LabManager).
•    System configuration as applicable.
•    Writing and reviewing test protocols and reports
•    Authoring / reviewing procedures in One Vault for all laboratories as needed.
•    Software systems User Access Review/Periodic Review/Audit Trail Review.
•    Training end users.
•    Working in a cross functional capacity between BT and the Laboratories to ensure both planned and unplanned systems downtime does not impact business function.

Education and Technical Skills:
•    Degree qualified in relevant scientific discipline.
•    Extensive knowledge of laboratory systems, ideally including validation testing, commissioning and decommissioning.
•    Proven track record in quality systems configuration/validation implementation OR support.
•    Knowledge of DI and CSV regulatory standards and compliance requirements 
•    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 prioritize competing priorities.

So, if all this sound like the right role for you, then apply today!

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

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