GxP Systems Specialist

Job Summary

A company is looking for a GxP Systems Specialist Senior.

Key Responsibilities

• Collaborate with IT to gather project requirements and manage compliance-related issues
• Support and maintain Quality programs ensuring compliance with cGMP expectations
• Conduct validation training and participate in cross-functional project teams

Required Qualifications

• Bachelor's Degree in a related field or foreign equivalent
• Five years of GxP computer systems experience in a regulated industry
• Experience with computerized systems regulations, including CFR Part 11
• Knowledge of Quality Systems and cGMP requirements
• Experience in validation methodology and software development life cycle principles