OT Compliance Lead – GAMP 5 & GxP Systems

Pauwels Consulting; Gent; Sur place; EUR 55 000 - 70 000; Plein temps

Résumé du poste

Pauwels Consulting seeks an Operational Compliance Associate to guard GxP compliance of industrial IT assets and oversee the daily maintenance of OT systems in a pharma environment. You will monitor OT assets, manage access controls, support investigations and CAPA closure, perform CSV activities per GAMP 5, and keep SOPs up to date.

English proficiency is required; Dutch is a plus. You will coordinate with QA and IT teams, ensure traceability and documentation, participate in audits, and

Qualifications

• Bachelor or Master degree in Engineering, IT, Science or related discipline.
• In-depth knowledge of GMP standards, 21 CFR Part 11, EU GMP Annex 11, Data Integrity and GAMP 5 guidelines.
• Familiarity with ISA-88 and ISA-95 industrial standards.

Responsabilités

• Monitor and maintain operational technology assets to ensure operability and compliance within a GxP environment.
• Manage user access controls and follow up on incidents to support rapid service resolution.
• Support investigations and root cause analyses while tracking CAPAs to ensure timely closure.
• Perform and document audit trail reviews and routine maintenance tasks such as system patching and upgrades.
• Execute Computer System Validation (CSV) activities, including protocols and test scripts, in alignment with GAMP 5 requirements.
• Update Standard Operating Procedures (SOPs) and work instructions to uphold documentation standards and GDocP principles.

Connaissances

Fluent English

Dutch (C1)

GxP compliance

CSV

GAMP 5

Formation

Bachelor or Master degree in Engineering, IT, Science

Description du poste

Pauwels Consulting seeks an Operational Compliance Associate to guard GxP compliance of industrial IT assets and oversee the daily maintenance of OT systems in a pharma environment. You will monitor OT assets, manage access controls, support investigations and CAPA closure, perform CSV activities per GAMP 5, and keep SOPs up to date.

English proficiency is required; Dutch is a plus. You will coordinate with QA and IT teams, ensure traceability and documentation, participate in audits, and