Job Title: Qualified Person / Responsible Person (QP/RP)
Dublin

A highly experienced and eligible Qualified Person (QP) is sought to take on a pivotal role within the organisation, responsible for certifying products in accordance with EU Directives 2001/83/EC, 2003/94/EC, and Annex 16. The successful candidate must meet the requirements to act as a European QP.

Key Responsibilities:

• Oversee and maintain the Quality Management System (QMS), ensuring it is effective, compliant, and continuously improved as necessary. Approve SOPs and associated Quality System documentation.

• Ensure robust quality processes are in place and maintained to support the organisation’s authorisations (WDA, MIA, ASR) and Marketing Authorisation Holder (MAH) responsibilities.

• Act as the primary liaison with the HPRA, representing the company in all communications and regulatory interactions.

• Provide expert QA support and lead the resolution of any quality issues to closure.

• Support HPRA inspections, including preparation and follow-up of inspection responses.

• Facilitate internal compliance audits in collaboration with corporate quality teams.

• Prepare and approve variations for HPRA submissions.

• Offer QA oversight and expertise for New Product Introductions.

• Review and approve Quality Events, including Non-Conformances (NCs), CAPAs, Change Controls, and complaints.

• Perform QP batch certification, ensuring that each batch has been manufactured and checked in compliance with applicable legislation in the certifying Member State, specifically for Externally Manufactured Products.

• Develop, maintain, and approve Quality Agreements in alignment with global standards, ensuring they are current, accessible, and compliant.

• Conduct regular reviews of the QMS and operational procedures for regulatory compliance through a defined internal audit system.

• Support and contribute to periodic Management Review meetings.

• Initiate Change Controls where applicable.

• Prepare and deliver annual GMP and GDP training sessions.

• Maintain effective and timely communication with global colleagues.

• Ensure full adherence to data integrity requirements at all times.

Person Specification:

• BSc (Hons) in a scientific discipline or equivalent.

• Comprehensive knowledge of GMP and GDP regulations and requirements for medicinal products and medical devices.

• Minimum of 5 years’ experience in a Quality Assurance role within the healthcare sector.

• Proven ability to work independently and collaboratively within cross-functional teams.

• Strong analytical skills with the ability to resolve complex quality issues.

• Excellent organisational and communication skills.

• Demonstrated track record of delivering results and influencing internal and external stakeholders.

• Ability to build strong working relationships at all levels.

• Trained internal auditor.

• Willingness and flexibility to travel as required to support business needs.