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.Requirements: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
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