Qualified Person (QP)
AbbVie, Inc
Irel
5d ago

is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions.

The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas : immunology, oncology, virology and neuroscience.

In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world.

For more information about AbbVie, please visit us at

AbbVie : Determined to Make a Difference Updated

People. Passion. Possibilities. Those three simple words mean everything at AbbVie, where patients always come first. So do cutting-

edge science and innovation, which fuel our expanding pipeline as we take on the world's toughest health challenges in oncology, immunology, liver disease, women's health and beyond.

Together, we strive to make a difference for patients around the world. For more visit : www.abbvie.com.

I chose a thriving career with AbbVie and the #1 Great Place to Work .

At AbbVie, our strength lies in our team of experts who conduct ground breaking science on a global scale every day. In choosing your career & life path, choose to be extraordinary!

Based in Carrigtwohill, on the outskirts of Cork, we manufacture solid and capsule formulations in a modern bulk tablet’ finish facility.

We focus on innovative new technologies and with our high performing team; we develop and deliver products and processes to support AbbVie’s wider global needs.

These range from small scale clinical trial supply to large commercial manufacturing.

We are always looking for talented people to join our team and, when we find them, we make it our business to treat them well.

Choose AbbVie if you share our passion for improving the health and lives of patients. To learn more about AbbVie in Ireland, please click on

We are currently sourcing a Qualified Person (QP) to join our high performing quality team. In this role, you will :

Release of Finished and Semi-Finished Products

To meet Internal & External cGMP Requirements

By assisting in the completion of Annual Product Review (data collection, graphic analysis )

By participating to the review and updating of the regulatory filing (US & European, DMF type 1 ), with the collaboration of the regulatory department.

By completing quality assurance review of batch documentation as required :

  • By making sure that critical deviations are investigated and resolved- Set up a performance indicator- Decide efficiently what is to be done with products
  • By ensuring the follow-up of the necessary corrective actions implemented in consequence of a quality failure

    By reviewing and assessment of GMP critical systems

    Participating and follow-up the audits and / or inspections carried out at the site by the authorities or clients, propose corrective actions and check that they are applied.

    Participate in technical and scientific meetings, in training days, trade fairs, conferences (technological intelligence ).

    Provide to operations all guidelines and documents.

    Keep up-to-date with the Regulation Evolution

    Contribute to the Quality Assurance Plan Realisation

    Education to meet the requirements for position of Qualified Person as defined in EU GMP volume 4 and annex 16.

    Experience to requirements for position of Qualified Person as defined in EU GMP volume 4 and annex 16

    Relevant 3rd honours degree with 3 yrs practising QP experience preferred

    2 yrs QA industrial experience in pharma

    Apply
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