Key Facts

Remote From:

Freelance

Senior (5-10 years)

English

Hard Skills

Computer System Validation MAMP Title 47 CFR Part 15 Root Cause Analysis Regulatory Compliance Automation Controls Clinical Auditing

Other Skills

•
Troubleshooting (Problem Solving)
•
Teamwork
•
Communication

Roles & Responsibilities

10-15+ years of Computer System Validation experience
Experience with cGxP, 21 CFR Part 11, GAMP and other compliance regulations and procedures
Experience investigating and troubleshooting automation and control systems (root cause analysis)
Ability to work in cross-functional team environments as well as independently

Requirements:

Perform computer system validation activities in compliance with cGxP, 21 CFR Part 11, GAMP and related regulations
Investigate and troubleshoot automation and control systems, including root cause analysis
Collaborate with cross-functional teams and manage validation deliverables independently as needed
Support external audits by agencies such as FDA, MHRA

Georgia IT, Inc.

About Georgia IT, Inc.

Georgia IT, Inc. provides IT Consulting for a wide range of IT services and custom build turn-key enterprise solutions. GIT specializes in improving business scalability and efficiency through BSM and SBA Solutions. GIT transforms business with service management and service automation solutions. We are BMC & HP partners. GIT Services include custom built enterprise software and customer-centric web portals, network design and implementation, remote and site-to-site VPN, network and server security assessment and setup, server and desktop virtualization, and many others. GIT also provides IT Consulting in many areas such as Disaster Recovery Planning, Enterprise Data Backup Strategy, Long Term Strategic IT Planning and Augmentation Professional Services Solutions. Professional Services Specialties: Business Process Integration, Software Integration & Development, Web portal, Networking, Remote and site-to-site VPN, Virtualization Solutions, Product Development Please contact us Hrus@georgiait.com / uthay@georgiait.com/470-798-5000 x 1010 / (732) 890-2535 direct

Founded: 2018

Company size: 51 - 200

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Job description

Senior Validation Consultant – remote to start
Location         : Somerset, NJ
Duration        : 6 month, extension possible
Rate                : DOE

US Citizens Green Card , GC EAD and H4 EAD accepted.

Description

10-15+ years of Computer System Validation experience
Experience with cGxP, 21 CFR Part 11, GAMP and other compliance regulations and procedures
Experience investigating and troubleshooting automation and control systems (root cause analysis)
Ability to work in cross-functional team environments as well as independently
Strong written and verbal communication skills
Experience with attending external audits from agencies such as FDA, MHRA, etc will be a plus