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

QA Specialist

Primary Sligo, Ireland Req ID 2212527 Category Quality Assurance Division AbbVie

Want to make a global impact? We offer that.

Want to be part of a Great Place to Work in Ireland? We offer that too.

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 QA Specialist to join our site in Manorhamilton Road, Sligo. The QA Specialist will coordinate the development and maintenance of company’s quality system in compliance with all applicable regulatory requirements and to ensure that products manufactured at AbbVie meet requirements of end users, of regulatory authorities and of the company. The Quality Specialist is responsible for documenting and establishing a quality system which ensures full compliance with all regulatory and AbbVie requirements.

Are you intrigued? Do you want to learn more?

A snapshot of your key responsibilities as a QA Specialist would be:

  • Execution of batch record review as required. 
  • Coordinating the quality system, ensuring full compliance by all personnel with its requirements.
  • Coordination of product quality review activities.
  • Coordination and management of all track and trend activities to support manufacturing and QC. 
  • Driving a QRM approach to all activities on site.
  • Assisting in auditing the quality system with other management personnel.
  • Assisting in the investigation of and coordinating customer complaints/exceptions by ensuring implementation of effective corrective / preventive action where necessary.
  • Ensuring that products manufactured at AbbVie Ireland Pharmaceutical Operations meet requirements of end users, of regulatory authorities and of the company.
  • Coordinating change control and Change plan activities.
  • Monitoring quality performance and advising management personnel on major quality issues.
  • Ensuring all plant personnel are fully aware of quality and cGMP requirements.
  • Initiation and Completion of Quality related ER’s as required.
  • Establishing Corrective / Preventive Action system and procedures.
  • Verification of effectiveness of corrective / preventive actions arising out of product, process and quality system non-compliance.
  • Implementation review for Policy documents.
  • Supporting all aspects inspection readiness including preparation activities, logistic activities, and generation of follow up responses and management of proof books.
  • Supporting and delivering on all Pharma III initiatives as assigned.
  • This position is crucial in identifying any causes of non-compliance of the quality system while maintaining effective communication with all employees within the plant and external auditors.
  • This position will assist in ensuring that the causes of deviations and nonconformances are identified and eliminated.
  • Adheres to and supports all EHS & E standards, procedures and policies.
  • Site Training Coordinator support - Manage, maintain and update an efficient electronic training management system- ISo Train by providing ongoing support to all departments to ensure a compliant system is in operation.
  • Documentation Controller Support - Control, distribution and archiving of documentation for the facility.

Education and Experience:

  • A Third level qualification in a science, quality or relevant discipline.
  • A minimum of two years’ experience in a quality role.
  • A strong knowledge of regulatory requirements is required.
  • Requires a high level of attention to detail and mental concentration, to ensure accuracy and total compliance with procedures at all times.

So, are you ready to join our team? 
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.

Travel: No
Job Type: Experienced
Schedule: Full-time

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