Test ManagerT-Systems Information and Communication Technology India Private Limited
We are seeking an experienced Test Manager with 9 to 12 years of expertise in developing and executing comprehensive testing strategies for clinical trial web applications. The ideal candidate will be responsible for creating validation master plans (VMP) and validation protocols in compliance with GXP requirements. You will define test approaches for various validation phases, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).Your role will involve establishing risk-based testing methodologies aligned with GAMP 5 principles and planning User Acceptance Testing (UAT) alongside clinical stakeholders. As a leader, you will mentor a team of test engineers and validation specialists, ensuring task allocation and monitoring performance against project timelines.In addition, you will conduct regular team meetings, provide technical guidance, and foster collaboration between testing, development, and quality assurance teams. You will also manage resource allocation and capacity planning to optimize team performance.Compliance and quality assurance are key aspects of this role, as you will ensure that all testing activities adhere to GXP, GCP, GLP, GMP, GDP, and GAMP guidelines. You will maintain traceability matrices linking requirements to test cases and defects, review and approve validation documentation, and coordinate with QA teams for regulatory inspections and audits.On the technical side, you will oversee functional, integration, system, and performance testing, validate data integrity, security, and audit trail functionality, and ensure compliance with 21 CFR Part 11 regarding electronic signatures. You will also coordinate testing of system interfaces and data migrations while managing testing environments and test data provisioning.Documentation and reporting are essential parts of your responsibilities, as you will create and maintain comprehensive test documentation, generate validation summary reports, and document deviations and CAPAs (Corrective and Preventive Actions). Regular status reports will be provided to stakeholders and senior management.Finally, you will collaborate with clinical operations, data management, and biostatistics teams and interface with regulatory affairs and quality assurance departments to ensure that all project requirements are met efficiently.
Feb 26, 2026