Data Integrity Consultant

MindCapture BV; Belgique; Sur place; EUR 60 000 - 90 000; Plein temps

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

At MindCapture you are not just starting a new role. You are joining a community that invests in your development and gives you the opportunity to grow in a meaningful technical career within healthcare.

You can count on:

• A competitive salary with a full benefits package including meal vouchers, eco vouchers, health insurance, group insurance, net expense allowance and a company car with charging or fuel card
• Personal growth support with tailored training and clear career development
• A stable environment where your technical skills directly contribute to improved patient care
• The chance to work with high tech diagnostic systems at top tier healthcare institutions
• A warm and collaborative culture focused on trust, ownership and long term impact

You will perform Data Integrity compliance reviews for small analytical equipment systems and associated computerised applications within Manufacturing and QC environments. Activities will follow defined protocols and standardised templates, with a strong focus on equipment interfaces, data flows, traceability, access management and remediation of identified gaps.

Key responsibilities

• GAP assessments: Identify compliance gaps and document appropriate 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

Required competences & skills

• Experience: One to three years of relevant experience in a strongly regulated environment
• GxP knowledge: Familiarity with GxP requirements for analytical equipment in Manufacturing or QC environments
• Data Integrity: Strong knowledge of Data Integrity principles and ALCOA++
• Data flows: Experience with data flows, audit trails, controls and access management
• Risk management: Knowledge of risk management and risk based approaches such as ICH Q9
• Analytical skills: Strong ability to analyse systems, processes and compliance risks
• Accuracy: High level of precision and attention to detail
• Independent working: Ability to work independently within structured protocols and standardised templates
• Communication: Strong communication skills for cross functional collaboration
  

CQV Antwerp Medior At MindCapture as consultant

About this application

This opportunity is offered through MindCapture as a consultancy role with strong day to day ownership. You will be placed on site with our client.

MindCapture supports you throughout your assignment with clear onboarding, regular follow up and access to learning opportunities. You will have a dedicated point of contact, transparent communication and support to help you deliver impact in a structured way.

Job Contact – Talent & Business Team

Our Talent & Business Managers combine a deep understanding of our clients’ needs with a sharp eye for talent. Their focus is on creating meaningful and sustainable matches, always keeping both the role and the candidate in mind.

When a potential match is identified, one of our T&B colleagues may reach out to answer your questions, share additional context about the role and discuss possible next steps together, with clarity and transparency throughout the process.

How our application process works

• Apply online – Submit your application in just a few clicks.
• Personal interview – If we see a potential match, our team reaches out to get to know you better, explore your skills and ambitions and hear what you value in your next challenge.
• Client introduction – We match you with potential projects and introduce you to clients where your expertise fits best.
• Client interview & feedback – You meet with the client to explore project details and expectations, while we support you throughout the discussions and provide follow-up afterwards.
• Final interview & welcome – In a final chat with our team, we close the process and warmly welcome you to MindCapture, guiding you towards a smooth start with us or at the client site.
• Manage material lifecycle act across quality and operations
• Improve compliance, continuity, cost control and OPEX
• Optimise processes, data and systems using digital tools
• Perform Data Integrity reviews for regulated equipment
• Assess data flows, controls and system traceability
• Identify compliance gaps and define remediation actions
• Build practical experience in CSV projects
• Support validation activities within GMP environments
• Create compliant technical documentation
• Support commissioning and qualification documentation
• Collaborate with engineering, quality and production teams
• Standardise technical documentation across multiple projects
• Coordinate stakeholders to improve structure and traceability
• Lead commissioning across complex systems
• Coordinate testing, acceptance and operational handover
• Ensure safe execution within strict regulated environments
• Lead validation for regulated digital technology platforms
• Ensure compliant computer systems and quality processes
• Support multidisciplinary teams with data integrity expertise
• Support compliant computer systems in R&D
• Drive validation and quality compliance
• Collaborate on data integrity across teams
• Technical field support for diagnostic systems
• Regional role with customer interaction
• Ideal for junior engineers who want impact
• Execute validation of GMP critical computerised systems
• Ensure compliance with FDA and EU regulatory standards
• Generate validation documentation and resolve issues
• Qualify and validate equipment and processes

We know timing is everything. If you don’t see a role that fits you right now, we still want to hear from you. Our consultants are always looking for talent, sometimes before the job even goes live. Drop us your CV and we’ll keep you in mind for future opportunities.