Pharma QA Specialist - Quality Systems & Compliance

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

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.