Key Responsibilities

• Plan, author, review, and execute CSV activities for GxP-regulated serialization and Track & Trace systems.

• Perform validation activities for TraceLink or equivalent serialization applications, interfaces, and related integrations.

• Develop, review, and maintain validation lifecycle documentation, including the following:

• Validation Plans

• User Requirements Specifications (URS)

• Functional and Design Specifications

• GxP and system risk assessments

• Installation Qualification, Operational Qualification, and Performance Qualification (IQ/OQ/PQ) protocols

• Test scripts and objective test evidence.

• Requirements Traceability Matrices (RTM)

• Validation Summary Reports

• Execute functional, integration, regression, and end-to-end validation testing for serialization systems and interfaces.

• Validate serialization processes including serial number management, commissioning, aggregation, EPCIS data exchange, partner onboarding, regulatory reporting, and exception handling.





• Apply risk-based validation and maintain traceability among requirements, risks, test cases, defects, and validation evidence.

• Document and investigate validation deviations, test failures, defects, and discrepancies, and support their timely resolution.

• Support system changes, upgrades, patches, enhancements, and integrations through established change-control and validation processes.

• Maintain validation documentation in an inspection-ready state and support internal audits, external audits, and regulatory inspections.

• Ensure compliance with 21 CFR Part 11, EU Annex 11, GAMP 5, GxP, data-integrity requirements, and electronic-record/electronic-signature controls.

Experience- 7+ Years

Location-Hyderabad

Notice Period- Maximum 30 Days

Note: Please do not apply if your official notice period is greater than 30 days else your profile would be rejected.

📌 Serialization with TraceLink Validation Tester (Hyderabad)
🏢 Cognizant
📍 Hyderabad