Quality Assurance Specialist: GMP, Release & Compliance

Next Generation (Ireland); Carlow; On-site; EUR 60,000 - 85,000; Full time

Job summary

Next Generation (Ireland) is seeking a Quality Specialist to provide oversight across material release, QMS, and GMP compliance within its Co. Carlow manufacturing environment. The role expands beyond lab testing into broader ownership of quality, documentation, and release processes.

You will work across Quality, Manufacturing, Engineering, Laboratory, Supply Chain and Technical Operations to ensure materials, products and processes meet defined standards and data integrity principles.

Qualifications

• Bachelor's degree in science, engineering, quality, biotechnology, pharmaceutical science, chemistry, microbiology or related technical discipline.
• Experience in a regulated pharmaceutical environment is required.
• Knowledge of GMP requirements applicable to pharmaceutical manufacturing.
• Experience reviewing batch records or manufacturing documentation.
• Product or material release experience and experience supporting new product introductions.

Responsibilities

• Provide quality oversight to keep manufacturing activities compliant and products moving.
• Support release of incoming materials and products manufactured or packaged externally.
• Review batch records, electronic manufacturing records, real-time reports and other quality documentation.
• Assist with new product/material introductions ensuring quality requirements are understood and implemented.
• Manage deviations, CAPAs, change controls, complaints, investigations and document management within the Quality Management System.
• Monitor quality events, performance and compliance metrics, identifying trends and areas needing attention.
• Escalate GMP and quality concerns that could affect product safety, efficacy, quality or purity.
• Collaborate with Quality, QA/QP and Business Area Specialists to resolve quality issues and provide guidance.
• Communicate quality expectations to suppliers and support site-level implementation.
• Identify opportunities to improve efficiency, compliance and effectiveness of quality and release processes.
• Maintain accurate, compliant records in line with Data Integrity and ALCOA+ principles.
• Support audit and inspection readiness by ensuring quality activities and documentation are robust and inspection-ready.

Skills

Quality Systems

Quality Assurance

Quality Compliance

Data Integrity

GMP

Documentation

Microsoft Office

Education

Bachelor's degree in science/engineering/quality

Tools

eQMS

MS Office

Job description

Next Generation (Ireland) is seeking a Quality Specialist to provide oversight across material release, QMS, and GMP compliance within its Co. Carlow manufacturing environment. The role expands beyond lab testing into broader ownership of quality, documentation, and release processes.

You will work across Quality, Manufacturing, Engineering, Laboratory, Supply Chain and Technical Operations to ensure materials, products and processes meet defined standards and data integrity principles.