GxP Systems and Support Administrator

Qualifications:

• Required
• Bachelor's degree in Information Technology, Computer Science, Life Sciences, or related field, or equivalent experience.
• 3–5+ years of experience administering IT systems and providing technical support.
• 2+ Years of experience administering GxP-regulated systems in a pharmaceutical, biotechnology, medical device, or related regulated environment.
• Experience supporting validated computer systems throughout their lifecycle.
• Working knowledge of FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and Data Integrity / Good Documentation Practices (GDP).
• Experience collaborating with Information Security & Quality departments to ensure system compliance with internal and regulatory requirements.
• Experience with change management, investigations, deviations and other Quality-related procedures.
• Experience with Entra identity management, access controls, SSO & SCIM integrations.
• Knowledge of backup, recovery, and disaster recovery procedures.
• Excellent troubleshooting, analytical, and documentation skills.
• Strong communication skills and ability to work with cross-functional teams.
• Preferred
• Experience administering CMMS, DVT or eQMS platforms in GxP environment
• Experience in GxP or Quality systems administration within a Professional Services or consulting organization
• #LI-MV1

Additional information