CSV Lead (Computer System Validation Lead)
AceStack LLC
Role: CSV Lead (Computer System Validation Lead)
Location: Remote
Contract
Job Summary
The CSV Lead will be responsible for leading and managing Computer System Validation (CSV) activities to ensure compliance with regulatory requirements such as FDA 21 CFR Part 11, GxP, and industry best practices. The role involves overseeing validation strategies, documentation, risk assessments, and coordination with cross-functional teams.
Key Responsibilities
Location: Remote
Contract
Job Summary
The CSV Lead will be responsible for leading and managing Computer System Validation (CSV) activities to ensure compliance with regulatory requirements such as FDA 21 CFR Part 11, GxP, and industry best practices. The role involves overseeing validation strategies, documentation, risk assessments, and coordination with cross-functional teams.
Key Responsibilities
- Lead end-to-end Computer System Validation activities for GxP-regulated systems
- Develop and execute validation plans, protocols, and reports (VP, IQ, OQ, PQ)
- Ensure compliance with FDA, EMA, 21 CFR Part 11, GAMP 5, and data integrity guidelines
- Perform risk assessments and define validation strategies based on system impact
- Review and approve CSV deliverables and validation documentation
- Coordinate with QA, IT, Business, and Vendors during validation lifecycle
- Support audits, inspections, and regulatory submissions
- Manage change control, deviation, CAPA, and periodic reviews
- Mentor and guide CSV team members and provide technical leadership
- Ensure validation activities align with SDLC and Agile methodologies
Vacancy posted 2 days ago
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