GxP Industrial IT Compliance Specialist

AMARIS GROUP SA; Belgique; À distance; EUR 65 000 - 90 000; Plein temps

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, incident support, CAPA tracking, and documentation of audit trails and maintenance tasks.

You will collaborate with IT and site stakeholders to uphold cGMP standards, data integrity, and regulatory guidelines while driving continuous improvement and change control processes.

Qualifications

• Experience with operational industrial IT systems in a regulated (GxP) environment.
• Proficiency in Microsoft Office and SharePoint.
• In-depth knowledge of GMP standards and related guidelines (21 CFR Part 11, EU GMP Annex 11, Data Integrity, ISA-88, ISA-95, ICH, FDA, FAGG/FAMHP, ISPE guidance).
• GAMP 5 guidelines for computerized systems.
• Knowledge of cybersecurity and NIS2 is a plus.
• Experience with SAP and ticketing systems is a plus.
• Bachelor or Master in Engineering/IT/Science.
• English fluent; Dutch is a plus.

Responsabilités

• Plan, perform, and follow up on operational industrial IT assets.
• Manage and monitor user access for OT systems.
• Follow up on incidents and support service resolution.
• Support investigations, deviations, and root cause analyses.
• Track CAPAs to ensure compliance and timely closure.
• Perform and document audit trail reviews.
• Schedule recurring maintenance tasks (patching, upgrades).
• Document actions taken and solutions implemented.
• Identify improvement opportunities and drive efficiency.
• Prepare and report on team meetings and Change Control Board meetings.
• Manage changes for existing operational industrial IT applications, including impact and risk assessments.
• Prepare and execute CSV validation activities, protocols, and test scripts per GAMP 5.
• Update SOPs, WIs, and forms for industrial IT assets.
• Ensure compliance with cGMPs, global regulatory requirements, safety standards, SOPs/WIs, and corporate policies.
• Uphold documentation standards and GDocP principles.
• Support industrial IT engineers in writing and executing protocols.
• Standardize general operational IT processes and update SOPs/WIs.

Connaissances

GxP compliance

OT systems

GAMP 5

21 CFR Part 11

EU GMP Annex 11

Data Integrity

ISA-88

ISA-95

ICH guidelines

ISPE guidance

SOPs/WIs

cGMP knowledge

Cybersecurity basics

SAP experience

Ticketing systems

English fluent

Dutch a plus

Formation

Bachelor/Master in STEM

Outils

Microsoft Office

SharePoint

SAP

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, incident support, CAPA tracking, and documentation of audit trails and maintenance tasks.

You will collaborate with IT and site stakeholders to uphold cGMP standards, data integrity, and regulatory guidelines while driving continuous improvement and change control processes.