CSV Consultant

Overview

On Site
Depends on Experience
Full Time

Skills

Auditing
PQ
Regulatory Compliance
SAP
SAP HANA
Supply Chain Management
System Administration
Change Control
Change Management
Computerized System Validation
GMP
GxP
Warehouse Management
Workflow

Job Details

Serve as the CSV (Computer System Validation) Lead for SAP S/4HANA Supply Chain & Warehouse Management modules
Partner with SAP configurators to document workflows, processes, and validation deliverables
Drive a risk-based validation approach in compliance with GxP and GMP standards
Focus on Performance Qualification (PQ) as a core element of the validation strategy
Provide oversight of digital computerized systems supporting the supply chain
Lead and support audits, change control processes, and periodic system reviews
Ensure compliance with 21 CFR Part 11 requirements, including audit trails and access management
Monitor ongoing system operations, including oversight of software providers and change management activities
Perform other duties, as needed

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