QA Specialist

Recruitment by Aphex; Waterford; On-site; EUR 42,000 - 62,000; Full time

Job summary

Recruitment by Aphex is seeking a QA professional on site in Waterford, Ireland, to safeguard product quality and cGMP compliance across manufacturing, storage and packaging.

You will review documentation and investigations, support audits, drive continuous improvement, and deliver GMP training to maintain audit readiness and regulatory standards.

Qualifications

• Deep knowledge of cGMP regulations.
• Excellent attention to detail.
• Strong interpersonal and presentation skills.
• Proficient in relevant computer packages.

Responsibilities

• Quality Oversight: serve as QA contact for systems/processes and review documentation, investigations, and reports.
• Compliance & Auditing: conduct internal audits and support regulatory inspections.
• Continuous Improvement: drive timely closure of quality actions and improve procedures.
• Training & Support: develop and deliver GMP training packages to uphold quality standards.

Skills

cGMP knowledge

Attention to detail

Interpersonal skills

Computer skills

Education

Third-level degree in Science or related

Job description

Purpose

To act as a key guardian of product quality and cGMP compliance on site. This role ensures that manufacturing, storage, and packaging processes meet regulatory standards while driving continuous improvement and audit readiness.

Responsibilities

• Quality Oversight: Serve as the primary QA contact for systems/processes, providing expert guidance on quality issues and performing critical reviews of documentation, investigations, and reports.
• Compliance & Auditing: Conduct internal audits and support supplier/regulatory inspections. Ensure all product deviations are resolved and closed prior to release.
• Continuous Improvement: Partner with operational teams to drive timely closure of quality actions, reduce recurring issues via trend analysis (RFT/data), and enhance procedures and practices.
• Training & Support: Support the development and delivery of GMP training packages to uphold site-wide quality standards.

Requirements

• Education: Third-level degree (Science or related discipline preferred).
• Experience: Minimum 2 years in a similar QA role within a cGMP-regulated environment.
• Skills: Deep knowledge of cGMP regulations; excellent attention to detail; strong interpersonal and presentation skills; proficient in relevant computer packages.

Personal Characteristics

• Accountability: Takes personal responsibility for actions and outcomes.
• Proactive: A self-starter who operates effectively under minimum supervision.
• Collaborative: Strong team player with excellent communication skills.
• Adaptable: Comfortable with change and focused on achieving tangible results in a dynamic environment.