Software QA Specialist

Responsibilities

• ▹Own QA review and approval across the SDLC: change control, test case review and approval, and test management
• ▹Support audits, CAPAs, and documentation control
• ▹Act as a key point of contact for customer quality questions, audit support, and questionnaires
• ▹Review quality assurance clauses in customer SLAs alongside the legal team
• ▹Get involved in the design and development of new features, including AI-based functionality, to ensure quality and regulatory requirements
• ▹Support the release of products into GxP environments
• ▹Provide QA review and approval across the GXP services offering, including consultant enablement and GLP scanning validation
• ▹Collaborate cross-functionally with the pre-clinical software development team and the AI/automation tooling team

Requirements

• ▹Minimum 3 years (5 preferred) of software development experience within a regulated environment
• ▹Genuine, hands-on GXP experience
• ▹Bachelor's degree in Computer Science or a related field
• ▹Experience with GLP software validation and verification
• ▹Comfort working in an Agile software development environment
• ▹Strong communication, collaboration, and problem-solving skills
• ▹Ability to work autonomously

Nice to have

• ▹Knowledge of GLP regulations: CSV/CSA, FDA 21 CFR 58, 21 CFR 11, OECD Principles of GLP, GAMP 5 (2nd edition)
• ▹Experience with cloud storage of GLP data
• ▹ISTQB or similar software testing certification
• ▹Hands-on experience with AI and automation in software development

Soft skills

What we offer

• ▹Competitive salary
• ▹Minimal travel, occasional trips for audits or team meetings

About the company

Patholytix, a subsidiary of Deciphex Ltd., works on regulated (GxP) software quality and AI-powered features for pharma and life sciences customers worldwide.