Compliance/Validation Specialist (freelance, part-time)
Yalantis
- Формат:
- повний remote
- Джерело:
- jobs.dou.ua
Що робити
- Define and support the compliance and validation approach for a GxP-regulated software system.
- Contribute to the validation strategy based on CSV/CSA principles and GAMP 5 framework.
- Review product requirements, workflows, architecture, and technical decisions from a compliance and validation perspective.
- Identify regulatory and validation risks related to audit trail, access control, electronic records / electronic signatures, data migration, integrations, and data integrity.
- Support the preparation and review of validation documentation, including risk assessments, validation plans, traceability matrices, test evidence, reports, and related artifacts.
Що очікуємо
- Experience with GxP-regulated software systems.
- Practical experience with CSV/CSA.
- Understanding of the GAMP 5 validation framework.
- Knowledge of EU GMP Annex 11 and 21 CFR Part 11.
- Understanding of data integrity principles, including ALCOA++.
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