Required Skills & Qualifications
67 years of experience supporting GxP systems in pharmaceutical, medical device, or clinical research environments.
• Hands-on experience with one or more systems including QMS applications, and laboratory systems.
• Strong understanding of GxP compliance, 21 CFR Part 11, Data Integrity principles, Incident and Change Management.
• Experience with ticketing systems, ServiceNow, JIRA, and ITSM processes.
• Robust troubleshooting and root cause analysis skills.
• Experience supporting production systems in regulated settings.
• Familiarity with database queries, application logs, and system configurations.
• Positive understanding of SDLC and validation concepts.
Preferred Qualifications
Exposure to pharmaceutical laboratory workflows.
• Experience supporting global users and cross-functional teams.
• Knowledge of validation documentation and change control processes.
• ITIL certification preferred.