Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries?PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees across Europe, Asia, and the Americas.Due to our constant growth, we are looking for a Software Quality Assurance Specialist to support our projects in Ireland.You will be responsible for:Leading the review and approval of SDLC deliverables, such as MVP, Risk Assessment (FMEA), Requirements, IQ, OQ, PQ, Trace Matrix, and System Release.Ensuring that IT validation packages are inspection-ready and comply with company policies and procedures.Working autonomously with IT contacts and business process SMEs to ensure effective validation of regulated IT applications.Supporting the implementation and validation of regulated IT systems by collaborating with development teams to ensure compliance and quality of deliverables.Reviewing and approving CAPAs, Change Controls, and Defects related to Software Validation while contributing to the validation strategy for IT changes.Driving continuous improvement by providing input into validation strategies and quality initiatives.Supporting or implementing automated testing solutions within validated environments.Collaborating with development teams to build compliance capabilities and ensure business requirements are met.Applying GxP regulations and validation principles to maintain a compliant state within IT and business systems.Providing regulatory guidance and compliance expertise to cross-functional project teams.About You:7+ years of experience in Software Quality Assurance (SQA) with strong experience reviewing and approving SDLC deliverables (MVP, Risk Assessment (FMEA), Requirements, IQ, OQ, PQ, Trace Matrix, and System Certification).Early career experience in SDLC/Software Validation, including writing and executing validation deliverables.Strong experience reviewing CAPAs, Change Controls, and Defects in a regulated software validation environment.Proven experience validating regulated IT systems.Previous experience with automated testing implementation.Solid understanding of GxP regulations, risk management principles, and industry best practices.Clear understanding of Waterfall and Agile methodologies and their application in regulated environments.Experience with tools such as JIRA, Confluence, Client-ALM, Tosca, Veera, Qtest, M-Files, Microsoft Teams, and familiarity with Data Lake, AWS, Databricks, GitHub, or other CI tools is a plus.Strong analytical mindset with the ability to organize work logically, thoroughly, and concisely.Highly self-motivated, self-directed, and confident working cross-functionally.Excellent written and verbal English communication skills, with the ability to provide regulatory guidance at all organizational levels.Must be authorized to work in Ireland and able to pass background and reference checks.Next Steps:Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview.If there's a positive match, a technical interview with the Hiring Manager will be arranged.In the case of a positive outcome following the Hiring Manager interview, the recruiter will contact you for further steps or to discuss our proposal.Alternatively, if the outcome is negative, we will contact you to halt the recruitment process.Working at PQE Group:As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group gives you the opportunity to work on international projects, improve your skills, and interact with colleagues from all corners of the world.If you are looking for a rewarding and exciting career, PQE Group is the perfect place for you.Apply now and take the first step toward an amazing future with us.