I chose AbbVie.
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 www.abbvie.ie or check us out on https://www.youtube.com/user/AbbVie
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
Fluent English - written & verbal
Job Type: Experienced
Job location: Ireland, Munster, Cork
Please click here to APPLY