GxP & System Validation Expert
Bekijk en reageer bij RED Global (externe link)
GxP & System Validation Expert voor ERP Cloud migratie in Life Sciences, hybride Krakau (Polen), start september 2026, freelance/contract.
- Locatie
- Krakow, PL
- Werkvorm
- hybride
- Contractvorm
- zzp
- Startdatum
- Eerste waarneming
- Uitgezet via
- RED Global
Eisen
- Strong experience in Computer System Validation (CSV)
- Experience with ERP implementation or Cloud migration projects
- Solid understanding of GxP / regulated Life Sciences environments
- Strong documentation and audit-readiness experience
- Strong understanding of risk assessments, qualification, testing and validation documentation
- Experience defining and executing validation strategies
- Ability to work in a hybrid environment in Krakow
- Experience working with Quality/QA, business and technical stakeholders
Wensen
- Experience with Infor M3
- Life Sciences / pharmaceutical / biotech experience
- Experience with regulated ERP transformation or migration programmes
- Direct experience supporting Infor M3 Cloud / ERP Cloud migration
- Knowledge of GAMP 5 and risk-based validation approaches
- Experience within manufacturing environments
- Experience supporting audits or inspections
Omschrijving
We are looking for an experienced GxP & System Validation Expert to support ERP Cloud migration activities within a regulated Life Sciences / manufacturing environment. The role will focus on Computer System Validation (CSV), GxP compliance and validation strategy, ensuring that ERP migration and deployment activities meet the required regulatory and quality standards. The ideal candidate will bring a combination of ERP Cloud migration, system validation, GxP/CSV and manufacturing experience, ideally with exposure to Infor M3. Key responsibilities include: defining and executing CSV/GxP validation strategies for ERP Cloud migration activities; ensuring ERP migration and implementation activities comply with relevant Life Sciences regulatory requirements and validation standards; developing and maintaining validation documentation throughout the project lifecycle; supporting system qualification, risk assessments, validation planning and execution; coordinating and supporting validation testing activities, including review and approval of test evidence; ensuring appropriate traceability between requirements, risks, testing and validation deliverables; supporting audit readiness and ensuring documentation is complete and inspection-ready; working closely with business, Quality, QA, IT and technical teams throughout testing and deployment; identifying validation and compliance risks and supporting appropriate mitigation activities; providing guidance on GxP expectations within ERP migration and system implementation activities; and supporting deployment/go-live activities from a validation and compliance perspective. Essential skills include strong experience in Computer System Validation (CSV), solid understanding of GxP / regulated Life Sciences environments, experience defining and executing validation strategies, experience with ERP implementation or Cloud migration projects, strong understanding of risk assessments, qualification, testing and validation documentation, experience working with Quality/QA, business and technical stakeholders, strong documentation and audit-readiness experience, and ability to work in a hybrid environment in Krakow. Highly desirable skills include experience with Infor M3, experience within manufacturing environments, direct experience supporting Infor M3 Cloud / ERP Cloud migration, Life Sciences / pharmaceutical / biotech experience, experience with regulated ERP transformation or migration programmes, knowledge of GAMP 5 and risk-based validation approaches, and experience supporting audits or inspections.
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