About the role
PROJECT INFORMATION: Industry: Pharmaceutical/ Healthcare.
Start: ASAP (flexible).
Contract: B2B 12 months + prolongations. (long term).
Remote: up to 100%
Location: remote/ Warsaw.
Project language: English.
Recruitment process: 2 interviews
The position can be performed remotely. Are you an experienced IT Validation Lead with a strong background in GxP validation, data migration, interfaces, and supplier assessment? Do you want to take validation responsibility for a large-scale migration from a legacy platform to a new regulated IT solution and help ensure that the migration and related integrations are compliant, controlled, and fit for intended use? Then please apply and become the newest member of our growing team.
This is a job for those who are excited to work with technologies, validation, testing, and quality control in agile IT projects. The main responsibility will be to lead validation activities for a large-scale GxP data migration while also supporting validation of interfaces and supplier assessments.
RESPONSIBILITIES:
- 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 together with business representatives, developers, IT QA, Process QA, and other relevant 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 in Development
REQUIREMENTS:
- 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
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