QA Specialist – Pharma/Devices | Cork (FTC)

AbbVie; Cork; On-site; EUR 55,000 - 75,000; Full time

Job summary

AbbVie in Cork is seeking a QA Specialist to join the Quality Assurance team on a fixed-term contract until September 2027. You will provide QA support for quality system requirements across pharmaceutical products, medical devices, combination products and biologics.

Responsibilities include supporting regulatory compliance, CAPA, audits, supplier controls, product quality reviews, and risk management. The role requires collaboration with cross-functional teams to ensure compliance with

Qualifications

• Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or related field preferred.
• 3+ years’ experience in quality assurance or relevant experience.
• Knowledge of QA systems and GxP compliance including regulations affecting device, biologics and pharmaceutical products.

Responsibilities

• Assist with integration and support of quality regulations across drug, biologics, device and/or combination products.
• Assist design of effective quality systems, procedures and/ or processes with cross-functional teams to ensure compliance and efficiency.
• Coordinate and support product actions within the affiliate, including reviews and CAPA.
• Perform assessments to ensure compliance and support inspections and audits including CAPA tracking.
• Coordinate investigations of deviations, non-conformances, product complaints and action plans.

Skills

Quality assurance

Regulatory compliance

GxP knowledge

Communication skills

Computer skills

Education

Bachelor’s Degree in technical/scientific field

Tools

SolTraqs

EBR

SAP

Job description

AbbVie in Cork is seeking a QA Specialist to join the Quality Assurance team on a fixed-term contract until September 2027. You will provide QA support for quality system requirements across pharmaceutical products, medical devices, combination products and biologics.

Responsibilities include supporting regulatory compliance, CAPA, audits, supplier controls, product quality reviews, and risk management. The role requires collaboration with cross-functional teams to ensure compliance with