Quality Assurance Manager

ACCPRO; Leinster; On-site; EUR 80,000 - 110,000; Full time

Job summary

ACCPRO in Ireland seeks an experienced QA Manager to lead the site's Quality Management System within a GMP-regulated packaging environment. You will drive quality assurance activities across production, lead CAPA and audits, and deliver KPI-driven improvements for compliance and operational excellence.

The role reports to Corporate QHSE Director (Italy) and MD Ireland, requiring strong cross-functional collaboration, supplier audits, and risk assessment.

Qualifications

• Experience in QA/Quality Management within regulated manufacturing environments.
• Solid understanding of GMP and ISO 9001 requirements.

Responsibilities

• Manage and maintain the site Quality Management System (QMS).
• Control and maintain quality documentation and records.
• Provide quality support to production and operational teams.
• Review and approve production batches in accordance with quality procedures.
• Lead investigation and resolution of quality deviations, non-conformances, and customer complaints.
• Manage CAPA activities and ensure effective implementation of corrective and preventive actions.
• Conduct risk assessments and support risk management activities.
• Oversee validation activities and change control processes.
• Plan and conduct internal audits and supplier audits.
• Lead customer, certification body, and regulatory audits.
• Monitor quality KPIs, identify trends, and drive improvements.
• Prepare and present quality reports to senior management.
• Support and lead continuous improvement projects.
• Deliver quality-related training across the organisation.
• Manage calibration systems and ensure measuring equipment remains compliant.

Skills

Quality Assurance

GMP knowledge

ISO 9001

Audits

CAPA

Risk assessment

Validation

Change control

Documentation

Stakeholder management

MS Office

Tools

ERP systems

MS Office

Job description

QA Manager

Location: Tullamore, Co. Offaly

Industry: Pharmaceutical Packaging Company

Reporting To: Corporate QHSE Director (Italy) and MD Ireland

About the Role

We are seeking an experienced QA Manager to lead and maintain the site's Quality Management System within a regulated pharmaceutical packaging environment. This role will be responsible for ensuring compliance with GMP and ISO standards, supporting manufacturing operations, driving continuous improvement initiatives, and overseeing all quality assurance activities across the facility.

Key Responsibilities

• Manage and maintain the site Quality Management System (QMS).
• Control and maintain quality documentation and records.
• Provide quality support to production and operational teams.
• Review and approve production batches in accordance with quality procedures.
• Lead the investigation and resolution of quality deviations, non-conformances, and customer complaints.
• Manage CAPA activities and ensure effective implementation of corrective and preventive actions.
• Conduct risk assessments and support risk management activities.
• Oversee validation activities and change control processes.
• Plan and conduct internal audits and supplier audits.
• Lead customer, certification body, and regulatory audits.
• Monitor quality KPIs, identify trends, and drive improvements.
• Prepare and present quality reports to senior management.
• Support and lead continuous improvement projects.
• Deliver quality-related training across the organisation.
• Manage calibration systems and ensure measuring equipment remains compliant.

Requirements

• Minimum 3 years' experience in a Quality Assurance or Quality Management position.
• Experience within pharmaceutical, pharmaceutical packaging, medical device, GMP-regulated, or similarly regulated manufacturing environments.
• Strong knowledge of GMP requirements and quality systems.
• Experience managing deviations, CAPAs, audits, risk assessments, validation, and change control activities.
• Knowledge of ISO 9001 and quality auditing standards.
• Strong organisational, analytical, and problem-solving skills.
• Excellent communication and stakeholder management abilities.
• Proficient in Microsoft Office applications, particularly Word and Excel.
• Experience working with ERP systems.

Additional Information

• Occasional international travel may be required.
• Applicants must have the right to work in Ireland.