CSV Validation Lead

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DXC Technology Magyarország Kft.
Munkavégzés helye

Hibrid • Budapest

Munkaidő, foglalkoztatás jellege
- Alkalmazotti jogviszony
- Általános munkarend
Elvárt technológiák
- TESTING SAP CLOUD
Elvárások
- Angol középfok
- 5-10 év tapasztalat
- Főiskola

Állás elmentve

A hirdetést eltávolítottuk a mentett állásai közül.

Responsibilities

Lifecycle validation of computer systems
Development of validation frameworks
Management of risk-based testing strategies
Ensuring IT systems fit for intended use and maintain data integrity
Development and maintenance of the Validation Master Plan (VMP)
Definition of validation scope using risk-based approach
Creation, review, and approval of core validation deliverables
Management of IQ, OQ, and PQ execution
Documentation, investigation, and closure of deviations
Subject matter expertise for ALCOA+ principles
Representation during internal audits and external regulatory inspections
Defense of validation packages to auditors
Technical audits of software vendors and SaaS providers
Review and approval of system changes to maintain validated status

Requirements

Expert knowledge of FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines
7+ years experience in CSV
At least 2 years leadership or coordination experience within a regulated industry
Experience validating platforms such as SAP S/4HANA, LIMS, QMS (TrackWise/Veeva), MES, or clinical trial systems
Understanding of validating SaaS/Cloud solutions and managing shared responsibility model
Uncompromising eye for documentation quality and audit-ready evidence
Ability to apply ICH Q9 principles for risk management
Ability to negotiate between IT and QA
Bachelor’s degree in Life Sciences, Engineering, Computer Science, or related technical field

Nice-to-have

Relevant certifications such as CISA, CSQE, or specific GAMP 5 training

What we offer

Full time employment
Project location Budapest – Hybrid
Ability to participate in virtual meetings across multiple time zones

Company info

DXC Technology (NYSE: DXC) helps global companies run their mission-critical systems and operations while modernizing IT, optimizing data architectures, and ensuring security and scalability across public, private, and hybrid clouds. The world’s largest companies and public sector organizations trust DXC to deploy services across the Enterprise Technology Stack to drive new performance levels, competitiveness, and customer experience.