Data Integrity Specialist at GE Healthcare

Eindhoven, North Brabant, Netherlands

GE Healthcare Logo
Not SpecifiedCompensation
Mid-level (3 to 4 years)Experience Level
Full TimeJob Type
UnknownVisa
Healthcare, Pharmaceuticals, Medical ImagingIndustries

Requirements

  • Minimaal een bachelor diploma in Life Sciences of gerelateerd vakgebied
  • Relevante ervaring in een QA rol binnen een farmaceutisch bedrijf
  • Relevante ervaring met Data Integrity in farmaceutisch bedrijf of verwante GMP-productie omgeving
  • Effectieve communicatie in het Nederlands en Engels (zowel schriftelijk als mondeling)
  • Ervaring in het geven van trainingen is een pre

Responsibilities

  • Het uitvoeren van DI Risk Assessments voor (electronische) systemen die GxP data genereren en opslaan
  • Zorgen dat alle geïdentificeerde acties tijdig worden uitgevoerd
  • Samenwerken met multidisciplinaire teams om te waarborgen dat GxP-data gegenereerd en beheerd worden volgens DI-eisen
  • Zorgen dat medewerkers op de locatie zijn getraind en zich bewust zijn van de DI-vereisten
  • Optreden als DI Subject Matter Expert (SME)
  • Op de hoogte blijven van de nieuwste richtlijnen en regelgeving over DI
  • Het uitrollen van de DI-strategie binnen de Radiofarmaca apotheken in Eindhoven, Zwolle en Leiderdorp, met inachtneming van de geldende GxP regelgeving

Skills

Data Integrity
DI Risk Assessments
GxP
Quality Management System
QA

GE Healthcare

Healthcare technology and data analytics provider

About GE Healthcare

GE Healthcare provides a range of healthcare technologies and services aimed at improving patient care. Its main products include imaging systems, mobile diagnostic devices, patient monitoring solutions, and advanced software for data analysis. These products help medical professionals make informed decisions and enhance the efficiency of healthcare delivery. Unlike many competitors, GE Healthcare invests significantly in research and development, allocating $1 billion each year to innovate and enhance its offerings. The company’s goal is to support healthcare providers in delivering better patient outcomes, as evidenced by its technology supporting over 300,000 patients daily and managing 2 billion patient scans each year.

Chicago, IllinoisHeadquarters
1892Year Founded
N/ACompany Stage
Data & Analytics, HealthcareIndustries
10,001+Employees

Risks

Emerging AR technologies increase competition in medical imaging.
Regulatory challenges may delay AI application expansions in healthcare.
Dependence on clinical trial success for new product market positioning.

Differentiation

GE Healthcare invests $1 billion annually in R&D for product innovation.
The company supports over 300,000 patients daily with its healthcare technologies.
GE Healthcare's AIR Recon DL offers 3D motion-insensitive imaging for enhanced MRI quality.

Upsides

Acquisition of Caption Health expands AI-powered ultrasound capabilities.
Successful Phase III trial of [18F]flurpiridaz enhances coronary artery disease detection.
Collaboration with Wayra accelerates digital health innovation in EMEA.

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