Industrial IT Compliance & Validation Specialist

MindCapture; Belgique; Sur place; EUR 65 000 - 90 000; Plein temps

Avantages offerts par ce poste

Meal vouchers

Eco vouchers

Health insurance

Group insurance

Net expense allowance

Company car with charging or fuel card

Résumé du poste

MindCapture seeks an Industrial IT Operational Compliance Associate to maintain GxP compliance and operability of industrial IT assets on-site with top healthcare institutions in Belgium. You will monitor, validate, and document systems, collaborate with IT, OT, engineering and quality stakeholders, and contribute to quality events and continuous improvement.

The role focuses on daily operations, access controls, validation activities, and adherence to GMP and data integrity standards, with a

Qualifications

• Bachelor or Master in Engineering, IT, Science or related discipline.
• GMP knowledge and pharmaceutical guidelines understanding.
• GAMP 5 principles for computerised systems knowledge.
• Familiarity with electronic records, data integrity and regulated systems.
• Interest or knowledge of industrial IT and OT systems.
• Proficiency with Microsoft Office and SharePoint.

Responsabilités

• System monitoring of industrial IT assets to maintain operability and compliance.
• Manage, control and monitor user access across systems.
• Support incidents, investigations, deviations, root cause analyses and CAPAs.
• Perform and document audit trail reviews.
• Schedule and perform maintenance including patching and upgrades.
• Assess impact and risk for changes to industrial IT apps.
• Prepare and execute validation activities per GAMP 5.
• Update procedures and system documentation with good practices.
• Maintain alignment with GMP requirements, data integrity and regulatory standards.
• Identify opportunities for process improvement and efficiency.

Connaissances

GMP knowledge

Validation knowledge

Regulatory knowledge

IT and OT

Cybersecurity

English

Dutch

Formation

Bachelor or Master degree in Engineering, IT, Science

Outils

Microsoft Office

SharePoint

Description du poste

MindCapture seeks an Industrial IT Operational Compliance Associate to maintain GxP compliance and operability of industrial IT assets on-site with top healthcare institutions in Belgium. You will monitor, validate, and document systems, collaborate with IT, OT, engineering and quality stakeholders, and contribute to quality events and continuous improvement.

The role focuses on daily operations, access controls, validation activities, and adherence to GMP and data integrity standards, with a