CSV/CSA Validation Consultant — GxP Software Systems (freelance, part-time)
Yalantis
- Формат:
- повний remote
- Джерело:
- jobs.dou.ua
Що робити
- 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.
Що очікуємо
- 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.
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