IT Validation Lead – GxP Data Migration

33 - 37 EUR/ godz./ godz.B2BB2B (netto)

SeniorFull-time·B2B

#412006·Dodano 5 dni temu·0

Źródło: nofluffjobs.com

Tech Stack / Keywords

ValidationGXPData migrationData mapping

Strong experience in IT Validation within pharma or another regulated industry, with the ability to lead validation activities independently
Hands-on experience with validation of GxP data migrations, including data mapping, transformation, reconciliation, migration testing, and migration reporting
Experience with validation of system interfaces and integrations, including APIs or other automated data transfers and related control mechanisms
Experience with GxP supplier assessment, including evaluation of supplier capabilities, quality processes, documentation, and validation evidence
Strong knowledge of GxP, data integrity, risk-based validation, quality processes, and risk identification, with a quality-focused mindset
Degree in Computer Science, Engineering, Software Development, Life Sciences, or a related field
Experience with large-scale projects and agile methodologies
Familiarity with Azure DevOps, test management, and test automation is advantageous
Skilled in stakeholder management and communication, ensuring timely involvement of key stakeholders such as LoB, IT QA, Process QA, Business Owners, Architects, IT Security, and suppliers
Promotes a healthy and collaborative working environment and is comfortable driving tasks, decisions, and follow-up across multiple teams

Own and drive GxP validation activities for the migration from a legacy system to a new regulated IT solution
Define and maintain the migration validation approach, including validation plans, risk assessments, test documentation, reports, and traceability
Support definition and verification of the migration process, including data mapping, transformation rules, reconciliation, completeness and accuracy checks, exception handling, and migration evidence
Plan, coordinate and execute migration testing with business representatives, developers, IT QA, Process QA, and other stakeholders
Assess and validate interfaces and integrations between regulated IT systems, including data transfer controls, error handling, reconciliation, and interface testing
Perform or coordinate GxP supplier assessments and evaluate supplier documentation and controls as input to the validation approach
Manage validation deviations, defects, risks, and follow-up actions through resolution and documented closure
Work independently as Validation Lead, take responsibility for validation deliverables, and participate as the validation expert in large-scale IT projects

Ework Group

87 aktywnych ofert