GxP Operational IT Compliance Specialist

Amaris Consulting; Gent; Sur place; EUR 55 000 - 85 000; Plein temps

Avantages offerts par ce poste

Health insurance

Remote work

Meal vouchers

Time savings account

Referral bonus

Résumé du poste

Amaris Consulting is seeking an Operational Compliance Associate to ensure GxP compliance of operational industrial IT assets at client sites. The role involves daily follow-up, troubleshooting, monitoring, and maintenance of OT systems, interacting with end-users and IT teams to uphold regulatory standards.

Applicants should have experience with regulated environments, GMP/GDP knowledge, and familiarity with SAP and ticketing systems.

Qualifications

• Experience in a regulated (GxP) environment applying GMP/GLP/GDP principles.
• Knowledge of GAMP 5 guidelines for computerized systems.
• Familiarity with IT and OT systems in pharma/biotech settings.

Responsabilités

• Plan, monitor, and maintain operational industrial IT assets.
• Manage user access for OT systems.
• Follow up incidents and support resolution.
• Support investigations, deviations, and root cause analyses.
• Track CAPAs and ensure timely closure.
• Document audit trails and validation activities.
• Schedule recurring OT maintenance tasks.
• Update SOPs, WIs, and forms.
• Ensure GxP compliance and data integrity.
• Collaborate with engineers and stakeholders.

Connaissances

GxP compliance

Regulatory knowledge

OT/ICS

Documentation

SAP

Ticketing systems

Change management

ISA-88/95

Data integrity

NIS2

Formation

Bachelor or Master in IT/Engineering

Outils

SAP

SharePoint

Validation tools

Ticketing

Description du poste

Amaris Consulting is seeking an Operational Compliance Associate to ensure GxP compliance of operational industrial IT assets at client sites. The role involves daily follow-up, troubleshooting, monitoring, and maintenance of OT systems, interacting with end-users and IT teams to uphold regulatory standards.

Applicants should have experience with regulated environments, GMP/GDP knowledge, and familiarity with SAP and ticketing systems.