Specialist, Quality Assurance

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

Own Quality from Material Release to Manufacturing Compliance

Specialist, Quality Assurance

Quality isn't just about checking whether something meets a specification. It's about making the decisions, maintaining the systems and resolving the issues that allow pharmaceutical manufacturing to operate compliantly.

A leading pharmaceutical company in Co. Carlow is looking for a Quality Specialist to support its manufacturing operation across product and material release, Quality Management Systems, GMP compliance and new product introductions .

This is an opportunity for a Quality professional who has moved beyond purely laboratory-based testing and wants broader ownership across the manufacturing quality environment. You'll work across Quality, Manufacturing, Engineering, Laboratory, Supply Chain and Technical Operations, helping ensure materials, products, documentation and processes meet the required standards.

What you'll achieve (and why it matters):

You'll provide the quality oversight that keeps manufacturing activities compliant and products moving:

• Support the release of incoming materials and products manufactured or packaged externally
• Review batch records, electronic manufacturing records, real-time reports and other quality documentation
• Support the introduction of new products and materials onto site, ensuring quality requirements are understood and implemented
• Manage and support Quality Management System activities including deviations, CAPAs, change controls, complaints, investigations and document management
• Monitor quality events, performance and compliance metrics, identifying trends and areas requiring attention
• Escalate GMP and quality concerns that could affect product safety, efficacy, quality or purity
• Work closely with Quality, QA/QP and Business Area Specialists to resolve quality issues and provide practical guidance
• Communicate quality expectations to suppliers and support their implementation at site level
• Identify opportunities to improve the 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

Your edge (desired, not required):

• A Bachelor's degree in science, engineering, quality, biotechnology, pharmaceutical science, chemistry, microbiology or a related technical discipline
• 3-5 years' experience within a regulated pharmaceutical environment
• Practical experience working within Quality Systems, Quality Assurance or Quality Compliance
• Experience managing deviations, CAPAs, change controls, investigations, complaints and document management
• Knowledge of current GMP requirements applicable to pharmaceutical manufacturing
• Experience reviewing batch records or manufacturing documentation
• Product or material release experience
• Experience supporting new product introductions
• Experience with quality metrics, compliance monitoring, audits or inspection readiness
• Experience working with suppliers on quality requirements
• Strong analytical, organisational and problem-solving skills
• Excellent written and verbal communication skills, with confidence working across multiple functions
• Strong attention to detail and the ability to manage competing priorities
• Experience using electronic Quality Management Systems and Microsoft Office
• Relevant qualifications in Quality Management, Compliance, Auditing or Operational Excellence would be advantageous