A leading healthcare organisation is seeking an experienced Senior Quality Specialist to oversee and maintain the Quality Management System (QMS), acting as a Qualified Person (QP) under EU GMP and Responsible Person (RP) under EU GDP regulations. This is a permanent position based onsite their office in Dublin. This position offers a hybrid work model.

Key Responsibilities:

Manage and maintain the Quality Management System (QMS), ensuring it is fit for purpose.
Approve SOPs and quality system documentation.
Maintain compliance with WDA, MIA, and ASR authorisations.
Act as QP/RP and liaise with the HPRA on behalf of the company.
Support HPRA inspections and prepare written responses.
Oversee quality aspects of new product introductions.
Review and approve non-conformances, CAPAs, change controls, and complaints.
Manage supplier and customer GDP compliance reviews.
Ensure GMP-compliant batch record review before release.
Prepare, update, and review technical agreements with partners and third parties.
Conduct internal audits and management reviews.
Lead the implementation of continuous improvement initiatives within quality operations.

BSc (Hons) in Science or equivalent.
Eligible to act as a Qualified Person (QP) under Directive 2001/83/EC and 2003/94/EC.
Eligible to act as a Responsible Person (RP) per EU GDP guidelines is preferred.
Minimum 5 years’ experience in Quality Assurance within the healthcare industry.
Strong understanding of GMDPs and regulatory expectations.
Experience with internal audits and HPRA inspections.
Excellent analytical, communication, and leadership skills.
Ability to travel as needed.

For a confidential discussion about this opportunity, please contact Ranait Coughlan

(090) 6450664 (01) 66 200 8

Senior Quality Specialist (QP/RP Qualified)