Domain: Healthcare / Life Sciences 5-8 years of hands-on experience in Testing and Computer System Validation within the Healthcare / Life Sciences domain. 5+ years of strong practical experience with IQ, OQ, and PQ execution. 5+ years of in-depth knowledge of CSV methodologies and regulatory standards (FDA, GxP, GAMP 5). 5+ years of experience validating systems such as LIMS, QMS, ERP, EMR, or Clinical systems is a plus. Solid understanding of SDLC, STLC, and risk-based validation approaches. Ability to work independently and manage multiple validation activities simultaneously. Bachelor's degree in Engineering, Computer Science, Life Sciences, or a related field. Exposure to automation testing tools or test management tools is an added advantage. Prior experience working in regulated environments with general clients. Plan, execute, and document Computer System Validation (CSV) activities in compliance with regulatory requirements (GxP, FDA, EMA, etc.).



Develop and review validation deliverables including Validation Plans, Risk Assessments, IQ, OQ, PQ protocols, Traceability Matrices, and Validation Summary Reports. Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for computerized systems. Execute manual and automated testing activities aligned with validation requirements. Ensure compliance with 21 CFR Part 11, GAMP 5, and data integrity principles (ALCOA+). Collaborate with cross-functional teams including Quality, IT, Business, and Vendors. Support audits and inspections by preparing validation evidence and responding to audit queries. Participate in change control, deviation management, CAPA, and periodic reviews of validated systems. Provide guidance and mentorship to junior validation/test team members as needed.

📌 Software Qlty Assurance Sr. Specialist (Guadalajara)
🏢 Ntt Data
📍 Guadalajara