Senior Computer Systems Validation

Hace 4 días

, Puerto Rico ProQuality Network Jornada completa


Location:
East Puerto Rico
Work Setting: Onsite Availability: Immediate Position Overview We are seeking a Compliance Consultant to oversee and review Computer System Validation (CSV) and Equipment Qualification documentation, with strong C&Q, CQV, Engineering, Validation, and compliance SME expertise.

Key Responsibilities

- Review Validation Documentation, Master Plans, Protocols, and deviations for CSV, C&Q, CQV, qualification, and validation activities throughout the project lifecycle.
- Provide SME support across design, engineering, commissioning, qualification, and validation activities.
- Develop, review, and execute validation plans, protocols, reports, URS, risk assessments, and qualification documentation.
- Support validation of computerized systems, equipment, facilities, utilities, HVAC, and environmental systems.
- Review and support FAT/SAT, commissioning packages, and qualification deliverables.
- Apply cGMP, data integrity, and validation compliance requirements.
- Manage validation-related deviations, CAPA, troubleshooting, root cause analysis, and issue resolution.
- Coordinate execution with Engineering, Quality, Manufacturing, vendors, and contractors.
- Support audits, inspections, regulatory submissions, and validation program readiness. Find more details, view more opportunities, and apply directly here: https://app.loxo.co/proqualitynetwork