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

Overseeing lifecycle validation of computer systems for regulatory compliance
Developing and maintaining the Validation Master Plan (VMP)
Defining scope of validation efforts using risk-based approach
Leading creation, review, and approval of validation deliverables including User Requirements Specifications, Risk Assessments, Functional/Configuration Specifications, Validation Plans and Summary Reports
Managing execution of Installation, Operational, and Performance Qualification testing
Ensuring documentation and investigation of deviations
Acting as subject matter expert for ALCOA+ principles and data integrity
Representing CSV function during internal audits and external regulatory inspections
Performing technical audits of software vendors and SaaS providers
Reviewing and approving 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 in 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 attention to 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

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

Company info

DXC Technology 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.