Job Description
Responsibilities:
- 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.
Required Skills:- 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.
Numbers & Facts
| Location | Thousand Oaks, CA |
Skills
Change Controlunmatched
Computer Systemsunmatched
Corrective and Preventative Action (CAPA) Systemsunmatched
GMP (Good Manufacturing Practices)unmatched
GxPunmatched
Laboratory Information Management System (LIMS)unmatched
Laboratory Systemsunmatched
Labwareunmatched
Maintain Complianceunmatched
Process Validationunmatched
Regulationsunmatched
Regulatory Complianceunmatched
System Validationunmatched
Validation Documentationunmatched
Validation Testingunmatched
Writing Skillsunmatched
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