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Job Title: Validation Tester Job Type: Full-Time Location: Remote Job Summary: Join our customer's team as a Validation Tester and play a critical role in ensuring software quality and regulatory compliance. As a key member of our QA process, you will collaborate closely with developers and stakeholders, leveraging your expertise in validation testing and regulatory standards to drive product excellence. Key Responsibilities: Design and implement comprehensive test cases and scenarios using risk-based testing methodologies, with special emphasis on core functionalities and regulatory requirements. Execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols to validate applications and ensure compliance with industry regulations. Collaborate proactively with developers and stakeholders to understand, gather, and analyze application requirements for effective test coverage. Apply a breadth of testing methodologies, including UI/UX Testing and SQL Testing, to validate all aspects of the software solution. Log, track, and manage identified defects using test management tools, ensuring timely resolution and effective communication with relevant teams. Prepare accurate and detailed validation documentation, including test scripts, validation protocols, and summary reports in accordance with regulatory standards. Ensure all test cases and scenarios are traceable to system requirements and risk assessments, supporting robust and auditable validation processes. Required Skills and Qualifications: Proven experience in software testing and validation testing, particularly in regulated environments. Strong knowledge of regulatory standards such as GxP and FDA 21 CFR Part 11. Expertise in various testing methodologies, including UI/UX Testing, SQL Testing, and risk-based testing approaches. Exceptional written and verbal communication skills, with a demonstrated ability to convey complex information clearly and collaborate across teams. Experience with defect tracking and test management tools. Meticulous attention to detail and a commitment to delivering high-quality validation deliverables. Ability to work independently as well as collaboratively within a remote, cross-functional team. Preferred Qualifications: Experience preparing and reviewing validation documentation for regulated software products. Certifications in software testing or regulatory compliance (e.g., ISTQB, ASQ, or equivalent). Background in life sciences, healthcare, or other regulated industries. Show more Show less
