GxP Compliance Support

GxP IT Compliance Consultant Pharmaceutical Client

Engagement Type: Consultant / Contract

Function: IT Operations / Managed Services / Compliance
Experience: 812+ years, with hands-on experience supporting pharmaceutical or Life Sciences IT environments

Role Overview

We are looking for an experienced GxP IT Compliance Consultant / Subject Matter Expert to support our engagement with a leading pharmaceutical client.

The consultant will work closely with our IT Infrastructure, Service Desk, Operations, Service Delivery, Information Security and Quality teams to help them understand and consistently apply the GxP requirements relevant to the services being delivered to the client.

The primary objective of this engagement is to upskill the delivery team, assess current processes, identify compliance gaps and establish practical ways of working that meet the pharmaceutical client's GxP and audit requirements.

We are looking for a practitioner who can translate regulatory and quality requirements into clear, practical actions for IT support and operations teams.

Key Responsibilities

The consultant will be expected to:

• Understand the client's GxP environment, quality requirements and applicable IT compliance expectations.
• Assess the IT services being delivered to the client from a GxP compliance perspective.
• Identify gaps in existing processes, documentation, controls and team practices.
• Train and coach the IT support and operations teams on GxP principles relevant to their roles.
• Explain how GxP requirements apply to day-to-day IT operations and service management.
• Guide teams on appropriate documentation, evidence generation and record retention.

Provide guidance across areas including:

• Incident and Problem Management
• Change and Release Management
• Access and Privileged Access Management
• User provisioning and de-provisioning
• Backup and Restoration
• Disaster Recovery and Business Continuity
• Patch and Vulnerability Management
• Configuration Management
• System Monitoring and Logging
• Audit Trails
• Data Integrity
• Infrastructure Qualification
• Computerised System Validation / Computer Software Assurance
• Periodic Reviews
• Supplier / Service Provider Management
• Deviations and Corrective / Preventive Actions
• Documentation and Evidence Management

The consultant will also:

• Review existing SOPs, work instructions, operational procedures and controls applicable to the client environment.
• Recommend improvements required to align operations with client GxP expectations.
• Help develop or refine GxP-related SOPs, checklists, templates and operational procedures.
• Assist teams in understanding the importance of accurate, complete and contemporaneous documentation.
• Guide technical teams on maintaining appropriate audit evidence.
• Support preparation for client Quality reviews, assessments and audits.
• Conduct mock assessments or readiness reviews where required.
• Help establish clearly defined responsibilities between the pharmaceutical client, Anunta and other third-party service providers.
• Coach key members