Validation Specialist

Karwell Technologies

Thousand Oaks, CA
30+ days ago

Highlights

Support audits, inspections, and validation testing activities. Responsibilities: Lead validation activities for Labware LIMS 8 implementation.

Numbers & Facts

Location

Thousand Oaks, CA

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.

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