GxP CSA CSV Consultant
GxP CSA CSV Consultant with Benchling experience
Remote
$80/hr
Nestle
Job Description ::
We are seeking a highly skilled GxP CSA CSV Consultant with hands-on experience in Benchling to support the implementation, validation, and compliance of digital lab solutions in a regulated environment. The ideal candidate will have deep knowledge of Computer System Validation (CSV) and Computer Software Assurance (CSA) principles, and a strong understanding of GxP regulations
Key Responsibilities:
- Lead and execute CSA/CSV activities for Benchling implementation and upgrades.
- Develop and maintain validation documentation including risk assessments, validation plans, protocols, reports, and traceability matrices.
- Ensure systems are implemented and maintained in compliance with FDA 21 CFR Part 11, EU Annex 11, and other applicable GxP regulations.
- Collaborate with cross-functional teams including Quality, IT, R&D, and external vendors to ensure system compliance and readiness.
- Perform gap assessments and remediation planning for existing Benchling configurations.
- Support audit readiness and respond to regulatory inspections and internal audits.
- Provide training and guidance on CSA/CSV best practices and regulatory expectations.
- Contribute to continuous improvement initiatives in validation and assurance processes.
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