Quality Assurance Officer

The RFT Group; Dublin; On-site; EUR 60,000 - 80,000; Full time

Job summary

The RFT Group seeks a QA Specialist to support the MAH in maintaining an effective Pharmaceutical Quality System (PQS) and ensuring EU GMP/GDP compliance. You will provide operational quality support to the external Qualified Person and RP when applicable, coordinating QA activities with CMOs, CMOs and internal MAH functions.

Responsibilities include drafting SOPs, reviewing batch documentation, handling deviations, CAPAs, change controls, and quality reviews.

Qualifications

• Degree in Pharmacy, Chemistry, Biology, or related life sciences.
• Experience in pharmaceutical QA/GMP/GDP or MAH operations is required.
• Strong documentation and organisational skills.

Responsibilities

• Maintain and update PQS in line with EU GMP/MAH requirements.
• Draft/review SOPs, quality policies, and controlled documents.
• QA review of batch documentation prior to market release; track deviations and quality events.
• Support deviation management, CAPA, change control, and APR/PQR.
• Coordinate quality data exchange with CMOs, CLs, and external partners.
• Audit participation and follow-up on findings.
• Ensure quality agreements are maintained and followed.

Skills

Attention to detail

Communication

Teamwork

Multi-tasking

Problem solving

Education

Bachelor-level degree in Life Sciences

Job description

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.