Overview
Quality Assurance Officer Jobs in Dublin, County Dublin, Ireland at The RFT Group
Title: Quality Assurance Officer
Company: The RFT Group
Location: Dublin, County Dublin, Ireland
Job Description – QA Specialist
Location: Ireland. With possibility of going to Dublin occasionally.
Reporting to our client’s Responsible Person & Quality Operations Manager
Role Summary
The QA Specialist supports the Marketing Authorisation Holder (MAH) in maintaining an effective Pharmaceutical Quality System (PQS) and ensuring compliance with EU GMP/GDP requirements. The role provides operational quality support to the external Qualified Person (QP) and, when applicable, to the Responsible Person (RP). The QA Specialist coordinates quality activities with Contract Manufacturing Organisations (CMOs), Contract Laboratories (CLs), and internal MAH functions
Key Responsibilities
- Maintain and update the Pharmaceutical Quality System (PQS) in alignment with EU GMP and MAH requirements.
- Draft, review, and manage SOPs, quality policies, and controlled documents.
- Perform QA review of batch documentation prior to Market release. Track and follow up on deviations, OOS/OOT investigations, and quality events impacting batch release.
- Support change control, deviation management, CAPA tracking, and effectiveness checks.
- Coordinate and review Annual Product Quality Reviews (PQR/APR).
- Manage documentation related to distribution release, complaints, returns, recalls, stability studies
- Support qualification, monitoring, and performance review of API Manufacturers, CMOs and contract laboratories, distributors, services providers.
- Participate in audits and follow-up of audit findings.
- Ensure that quality agreements are maintained, updated, and followed.
- Coordinate quality data exchange and documentation flow with external partners.
- Maintain oversight of storage and transport conditions when required.
- Identify opportunities to strengthen processes and documentation.
- Contribute to quality metrics and management review inputs.
Qualifications & Experience
- Degree in Pharmacy, Chemistry, Biology, or related life sciences.
- 5 yrs experience in pharmaceutical QA, GMP/GDP compliance, or MAH operations.
- Knowledge of EU GMP (Part I, Annex 16) and GDP principles.
- Experience working with CMOs or outsourced manufacturing models is an advantage.
- Strong documentation, communication, and organisational skills.
Core Competencies
- Rigorous attention to detail and quality mindset.
- Strong communication and teamwork abilities.
- Ability to manage multiple tasks and deadlines.
- Analytical thinking and problem-solving skills.
- Proactive, flexible, and able to work in a small-company environment.
