Computer Software Assurance (CSA) Consultant

Computer Task Group, Inc•UNAVAILABLE, UNAVAILABLE

1d•Remote

About The Position

CTG is seeking an experienced Computer Software Assurance (CSA) Consultant to support validation and compliance initiatives for GxP-regulated IT systems within a pharmaceutical/life sciences environment. The ideal candidate will possess extensive experience with Computer Software Assurance (CSA), Computer System Validation (CSV), risk-based validation methodologies, and regulatory compliance. This role partners closely with business and implementation teams to ensure compliant system implementations, validation documentation, and successful project delivery.

Requirements

Deep expertise validating GxP-regulated IT systems within the pharmaceutical or life sciences industry.
Strong knowledge of Computer Software Assurance (CSA) and Computer System Validation (CSV) methodologies.
Experience with end-to-end IT validation and risk-based testing.
Comprehensive understanding of 21 CFR Part 11, Annex 11, ALCOA+, and GxP compliance requirements.
Hands-on experience with change control, CAPA, deviation management, and validation documentation.
Working knowledge of Veeva and ServiceNow platforms.
Excellent communication, documentation, analytical, and collaboration skills.

Nice To Haves

5+ years of CSA, CSV, or IT Quality experience in regulated environments.
Experience supporting enterprise software implementations and upgrades.
Ability to lead validation efforts while partnering effectively with business and technical teams.

Responsibilities

Lead CSA and CSV activities for GxP-regulated systems throughout the system lifecycle.
Develop and execute risk-based validation strategies and testing approaches.
Author and review validation deliverables, including Validation Plans, Test Strategies, Risk Assessments, Test Scripts, Traceability Matrices, and Validation Summary Reports.
Facilitate solution design sessions with implementation teams and business stakeholders.
Ensure compliance with 21 CFR Part 11, EU Annex 11, ALCOA+, ISPE CSA guidance, and internal quality standards.
Support Quality Management System (QMS) processes, including deviation management, CAPA, and change control.
Validate data migration activities and establish migration rules for system implementations.
Provide validation support for Veeva and ServiceNow applications.
Collaborate with cross-functional teams to deliver compliant, high-quality technology solutions.