QA Specialists

Aphex Group; Waterford; On-site; EUR 55,000 - 73,000; Full time

Job summary

Aphex Group is seeking a Quality Assurance professional on site to guard product quality and ensure cGMP compliance across manufacturing, storage, and packaging. The role focuses on audits, deviation resolution, and continuous improvement within a collaborative team environment.

The ideal candidate has a science degree and at least 2 years in a cGMP QA role, with strong attention to detail, communication, and IT skills. This position emphasizes proactive quality leadership and training delivery.

Qualifications

• Minimum 2 years in a similar QA role within a cGMP-regulated environment.
• Deep knowledge of cGMP regulations; strong attention to detail.
• Excellent interpersonal and presentation skills with proficiency in relevant computer packages.

Responsibilities

• Quality Oversight: act as the primary QA contact for systems and processes, reviewing documentation and investigations.
• Compliance & Auditing: support internal audits and regulatory inspections; ensure deviations are resolved before release.
• Continuous Improvement: drive timely closure of quality actions and update procedures; analyze trends to reduce issues.
• Training & Support: help develop and deliver GMP training to uphold site quality standards.

Skills

Quality Assurance

cGMP knowledge

Attention to detail

Interpersonal skills

Presentation skills

IT proficiency

Education

Science degree

Tools

MS Office

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.