Data Integrity Consultant - Healthcare QC

MindCapture BV

Belgique

Sur place

EUR 60 000 - 90 000

Plein temps

Il y a 7 jours
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Avantages offerts par ce poste

Meal vouchers
Eco vouchers
Health insurance
Group insurance
Company car with charging or fuel card

Résumé du poste

MindCapture BV offers a consultancy role performing Data Integrity reviews for regulated equipment in Manufacturing and QC environments. You will identify gaps, map data flows, and assess risk, working with cross-functional experts on defined templates to ensure compliance and traceability.

The position is on-site with our client, and MindCapture supports your development with onboarding, regular follow-up, and access to learning opportunities, while providing a dedicated contact for guidance

Qualifications

  • Experience in a strongly regulated environment.
  • Familiarity with GxP requirements for analytical equipment in Manufacturing or QC environments.
  • Strong knowledge of Data Integrity principles and ALCOA++.

Responsabilités

  • GAP assessments: Identify compliance gaps and document remediation actions.
  • Data Flow Mapping: Create and review digital or hybrid data flow mappings.
  • Risk assessments: Perform Data Integrity Risk Assessments using risk based methodologies.
  • Interface verification: Verify completeness and accuracy of data generation and transfer.
  • Audit trails: Assess audit trail functionality and system traceability.
  • Access management: Review user accounts, permissions and access controls.
  • Electronic data: Evaluate electronic data management processes and controls.
  • Security controls: Assess IT security measures and equipment controls.
  • Documentation: Create, update and review compliance documentation using standardised templates.
  • Collaboration: Work closely with system experts and cross functional stakeholders

Connaissances

Data Integrity
GxP knowledge
Analytical skills
Risk management
Independent work
Attention to detail
Communication

Outils

Documentation templates
Audit trails

Description du poste

MindCapture BV offers a consultancy role performing Data Integrity reviews for regulated equipment in Manufacturing and QC environments. You will identify gaps, map data flows, and assess risk, working with cross-functional experts on defined templates to ensure compliance and traceability.

The position is on-site with our client, and MindCapture supports your development with onboarding, regular follow-up, and access to learning opportunities, while providing a dedicated contact for guidance

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