Serialization with TraceLink Validation Tester

Job description

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.