KH
Validation Specialist
Katalyst Healthcares & Life Sciences
🇺🇸 United States
Hybrid
3 months ago
- GxP
- GMP
- Regulatory Compliance
- CAPA
3 months ago
- Lead validation activities for Labware LIMS 8 implementation
- Author and review IQ/OQ/PQ, RTM, and validation documentation
- Ensure compliance with GXP, CSV, and regulatory standards
- Support audits, inspections, and validation testing activities.
- Labware LIMS (Labware 8 Preferred)
- Computer System Validation (CSV)
- GXP / GMP Environment
- GAMP 5 & Regulatory Compliance
- IQ / OQ / PQ Documentation
- Requirements Traceability Matrix (RTM)
- Validation Strategy & Execution
- Audit Readiness & Inspection Support
- Deviation, CAPA & Change Control Management
- Laboratory Systems & Enterprise GMP Systems Validation.
Validation Specialist · Katalyst Healthcares & Life Sciences