CSV/CSA Validation Consultant — GxP Software Systems (freelance, part-time)

We are looking for a Senior CSV/CSA Validation Consultant for a healthcare project focused on building a regulated clinical/pharma patient monitoring system for the UK/EU market.

The product includes historical data migration, integrations, workflow engine, RBAC, 2FA, EU hosting, and full audit trail.

The main focus of the role is to build the validation strategy and CSV/CSA documentation for a GxP-regulated software system from scratch.

Responsibilities:

• Define validation strategy for a GxP-regulated software system.
• Build the CSV/CSA approach together with the project team.
• Prepare and support validation documentation: validation plan, risk assessment, traceability matrix, test evidence, validation report, SOPs, and related artifacts.
• Review requirements, workflows, architecture, and technical decisions from a validation and compliance perspective.
• Advise the team on GAMP 5, EU GMP Annex 11, 21 CFR Part 11, ALCOA++ data integrity principles, and GDPR requirements for health data.
• Support audit readiness and preparation for future regulatory or client-side validation activities.

Requirements:

• Hands-on experience with Computerized System Validation / CSV for software systems.
• Experience preparing validation strategy and validation documentation from scratch.
• Experience with GxP-regulated software systems.
• Practical knowledge of GAMP 5.
• Experience with EU GMP Annex 11 and/or 21 CFR Part 11.
• Experience with CSV/CSA and risk-based validation approaches.
• Understanding of audit trail, RBAC, electronic records / electronic signatures, data migration, integrations, and data integrity.
• English level: Upper-Intermediate or higher.

Will be a plus:

• Experience with SaMD or medical device software qualification.
• Experience in pharma / clinical / pharmacovigilance domains.
• Experience with products for the UK/EU market.

Before sending us your CV, you may read our Privacy Notice.