Quality Analyst

Job Title: Quality Analyst – Quality Management System (QMS)

Location: Kilkenny

Overview:

We are seeking a dedicated and detail-oriented Quality Analyst to support the effective operation and continuous improvement of our Quality Management System (QMS). Reporting to the Quality & Compliance Manager, the successful candidate will be responsible for document control, internal auditing, non-conformance investigations, and broader quality compliance support. This role plays a key part in helping the organisation meet its quality objectives, enhance operational performance, and maintain a culture of quality across all departments.

This position will also support the PRRC (Person Responsible for Regulatory Compliance) and contribute to quality reporting, audit readiness, and quality system enhancements in alignment with corporate and regulatory standards. Flexibility to take on additional tasks assigned by the Quality & Compliance Manager is essential.

Key Responsibilities:

• Manage the Documentation Compliance Manager (DCM) system and maintain the QMS document archive.
• Generate reports on QMS performance and compliance metrics for management review.
• Author, review, and maintain Standard Operating Procedures (SOPs).
• Administer the Change Control system and monitor implementation of approved changes.
• Manage internal process deviations and document-related non-conformances.
• Coordinate with cross-functional teams on compliance matters, including the delivery of retraining where needed.
• Oversee and resolve supplier and customer complaints.
• Plan and conduct internal audits of the QMS; support audit planning and coordination.
• Conduct supplier/outsourced service provider audits.
• Ensure site is prepared for external and corporate audits; provide on-site support during audits.
• Carry out environmental monitoring and testing as required.
• Ensure timely resolution and integration of audit findings, CAPAs, risks, and recommendations into the QMS.
• Lead or support investigations related to QMS issues and ensure CAPA implementation is effective and well-documented.
• Monitor and analyse quality data to identify trends, drive improvements, and inform decision-making.
• Share best practices and contribute to cross-functional continuous improvement initiatives.
• Communicate site compliance risks and ensure appropriate training and corrective actions are implemented.

Qualifications and Experience:

Required:

• A primary degree in Life Sciences, Engineering, or a closely related discipline.
  Alternatively, a relevant combination of education and experience will be considered.
• Minimum of 1 year of experience in a similar quality-focused role.
• Hands-on experience with QMS operations, document control, or process improvement projects.
• Participation in or execution of internal audits or similar compliance reviews.

Skills and Attributes:

• Excellent written and verbal communication skills.
• Strong attention to detail, organisation, and time management.
• Proactive problem-solving and critical thinking abilities.
• Ability to work independently and collaboratively in a cross-functional team environment.
• Flexible and adaptable to shifting priorities in a dynamic work environment.
• Results-driven with a focus on continuous improvement and delivering high-quality outcomes.
• Understanding of how quality supports overall business performance and regulatory compliance.
• Strong data analysis skills to support trending and reporting.

Desirable:

• Certification in auditing (e.g., ISO 9001 Lead/Internal Auditor).
• Qualification or training in:
• Quality Management Systems
• Lean or Continuous Improvement methodologies
• Quality auditing principles and best practices