Validation Engineer

3 weeks ago


Jersey City, United States CareerBuilder Full time

Responsibilities

:

Responsible for preparing and executing test documentation for GMP computerized systems as well as providing support in the troubleshooting of issues during test execution.

You should have excellent understanding of 21 CFR Part 11, ICH standards, EMA and FDA (GxP) regulations, and GAMP methodologies.

Coordinate with multi-disciplinary validation team and be responsible for the validation of automated equipment and control systems

Create and modify validation documentation including but not limited to: User Requirements Specifications (URS) Design Reviews (DR) Criticality assessments CSV protocols (SAT, IQ, OQ, PQ) which verify if the system is compliant to regulatory and client requirements

Reports which summarize the results of the protocol executions

Exception reports which identify defects or issues during test execution Review vendor documentation

Requirement Specification document review and approvals

System Implementation Plan Review

System Implementation Summary Report Review

Review and Pre-Approve ST/UAT Test Scripts in ALM

Create, Update RRA (Regulatory Risk Assessment) and obtain approvals

Post Execution Review and Post Approvals in ALM

gR Implementation Approvals

Retirement Plan Revew

Requirements:

Requirement document

Validation/Test Plan

Requirement Traceability Matrix

Change Requests

Impact assessment document

Test/Validation Summary Report

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