Operational Compliance Associate – GAMP 5 & OT 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

Our client, a leading organization in the pharmaceutical sector, is looking for an Operational Compliance Associate. This role guards the GxP compliance of industrial IT assets and manages the daily maintenance of operational technology systems.

Responsibilities

• Monitor and maintain operational technology assets to ensure continued 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.

Requirements

• You have a Bachelor or Master degree in Engineering, IT, Science, or a related discipline.
• You possess in-depth knowledge of GMP standards, 21 CFR Part 11, EU GMP Annex 11, Data Integrity, and GAMP 5 guidelines.
• You bring familiarity with industrial standards such as ISA-88 and ISA-95.
• You're proactive, detail-oriented, and capable of working independently under pressure.
• You are fluent in English.

Nice to Haves

• Knowledge of cybersecurity principles and NIS2 requirements.
• Experience with SAP, ticketing systems, Quality Event Management Systems, or Change Management tools.
• Familiarity with IT/OT systems integration within a pharmaceutical environment.
• Proficiency in Dutch at a C1 level.