Software QA Specialist

This is a fully remote position, open to applicants in Ireland.

📋 Description

• Oversee QA review and approval throughout the Software Development Life Cycle (SDLC) — including change control, test case review, and test management.

• Assist in audits, Corrective and Preventive Actions (CAPAs), and documentation control.

• Serve as a principal contact for customer quality inquiries, audit support, and questionnaires.

• Analyze quality assurance clauses in customer Service Level Agreements (SLAs) in collaboration with our legal team.

• Participate in the design and development of new features — such as AI-driven functionalities — to ensure compliance with quality and regulatory standards.

• Facilitate the release of products into Good Practice (GxP) environments for both internal and external regulated clients.

• Deliver QA review and approval within our GxP services portfolio, which includes consultant enablement and Good Laboratory Practice (GLP) scanning validation.

• Collaborate effectively with our pre-clinical software development team and our AI/automation tooling team.

⛳️ Requirements

• At least 3 years of software development experience in a regulated environment (5 years preferred).

• Authentic, hands-on GxP experience, with a clear understanding of what constitutes 'fit for purpose in a regulated environment.'

• A Bachelor's degree in Computer Science or a related discipline.

• Proficiency in GLP software validation and verification.

• Comfortable working in an Agile software development setting.

• Excellent communication, collaboration, and problem-solving abilities.

• Capability to work independently, taking ownership of tasks without needing prompting.

• Preferred: Knowledge of GLP regulations, Computer Software Validation/Computer Software Assurance (CSV/CSA), FDA 21 CFR 58, 21 CFR 11, OECD Principles of GLP, or GAMP 5 (2nd edition).

• Experience with cloud storage solutions for GLP data.

• ISTQB or a comparable software testing certification.

🏝️ Benefits

• Competitive salary.

• A highly collaborative, supportive, and multicultural team environment.

• Regular performance evaluations and authentic opportunities for career advancement.

• Minimal travel is required — occasional trips for audits or team meetings, with no regular on-site obligations.