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Описание: |
We are looking for a Senior Compliance/Validation Specialist to join a healthcare project focused on building a regulated clinical/pharma patient monitoring system from scratch.
The project is related to a system for controlled access and distribution of a prescription drug. The key product functionality includes historical data migration, integrations, workflow engine, RBAC, 2FA, EU hosting, and full audit trail.
The system may potentially fall under GxP regulations, including GVP/pharmacovigilance, EU GMP Annex 11, 21 CFR Part 11, GAMP 5 validation framework, ALCOA++ data integrity principles, and GDPR requirements for health data.
Responsibilities:
* 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.
* Advise the team on EU GMP Annex 11, 21 CFR Part 11, GxP, GVP/pharmacovigilance, ALCOA++ data integrity principles, and GDPR requirements for health data.
* Support the team in preparing the system for future audits, regulatory reviews, or client-side validation activities.
* Provide guidance on preliminary SaMD / medical device software qualification if applicable.
Requirements:
* 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++.
* Experience with GDPR requirements for health data.
* Experience contributing to validation strategy, risk assessment, documentation, and review of regulated software systems.
* Understanding of audit trail, role-based access control, electronic records / electronic signatures, data migration, and integrations in a regulated environment.
* English level: Upper-Intermediate or higher.
Will be a plus:
* Previous experience with SaMD or medical device software qualification.
* Experience in pharma / clinical / pharmacovigilance domains.
* Experience with products for the UK/EU market.
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