T-Systems Information and Communication Technology India Private Limited (T-Systems ICT India Pvt. Ltd.) is a proud recipient of the prestigious Great Place To Work® Certification™. As a wholly owned subsidiary of T-Systems International GmbH, T-Systems India operates across Pune, Bangalore, and Nagpur, boasting a dedicated team of 3500+ employees providing services to group customers. T-Systems offers integrated end-to-end IT solutions, driving the digital transformation of companies in all industries, including automotive, manufacturing, logistics, and transportation, as well as healthcare and the public sector. T-Systems develops vertical, company-specific software solutions for these sectors. T-Systems International GmbH is an information technology and digital transformation company with a presence in over 20 countries and a revenue of more than €4 billion. T-Systems is a world-leading provider of digital services and has over 20 years of experience in the transformation and management of IT systems. As a subsidiary of Deutsche Telekom and a market leader in Germany, T-Systems International offers secure, integrated information technology and digital solutions from a single source.

Experience    9 to 12 years

• Develop and implement comprehensive test strategies for clinical trial web applications
•   Create validation master plans  VMP  and validation protocols in accordance with GXP requirements
•   Define test approach for different validation phases  IQ  OQ  PQ
•   Establish risk based testing methodologies aligned with GAMP 5 principles
•   Plan and coordinate User Acceptance Testing  UAT  with clinical stakeholders
• Team Leadership   Management
•   Lead and mentor a team of test engineers and validation specialists
•   Assign tasks and monitor team performance against project timelines
•   Conduct regular team meetings and provide technical guidance
•   Foster collaboration between testing  development  and quality assurance teams
•   Manage resource allocation and capacity planning
• Compliance   Quality Assurance
•   Ensure all testing activities comply with GXP  GCP  GLP  GMP   GDP  and GAMP guidelines
•   Maintain traceability matrices linking requirements to test cases and defects
•   Review and approve validation documentation including test plans  protocols  and reports
•   Coordinate with QA teams for regulatory inspections and audits
•   Implement and maintain quality metrics and KPIs
• Technical Testing Activities
•   Oversee functional  integration  system  and performance testing
•   Validate data integrity  security  and audit trail functionality
•   Ensure proper testing of electronic signatures and 21 CFR Part 11 compliance
•   Coordinate testing of system interfaces and data migrations
•   Manage testing environments and test data provisioning
• Documentation   Reporting
•   Create and maintain comprehensive test documentation
•   Generate validation summary reports and executive dashboards
•   Document deviations  CAPAs  Corrective and Preventive Actions   and change controls
•   Ensure proper version control and document management
•   Provide regular status reports to stakeholders and senior management
• Stakeholder Management
•   Collaborate with clinical operations  data management  and biostatistics teams
•   Interface with regulatory affairs and quality assurance departments
•   Coordinate with vendors and third party service providers
•   Present testing results and validation status to executive leadership

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