GxP Certified Business Analyst

Job Summary

Working remotely during EST business hours, the part-time GxP Certified Business Analyst will gather and document requirements for business and technical initiatives in a GxP environment, ensuring successful delivery and compliance through the SDLC process.

Key responsibilities

• Support regulatory application enhancements and manage GxP requirements
• Facilitate the business requirements gathering process and document use cases and requirements for both waterfall and agile projects
• Develop necessary documentation for IT solution projects, ensuring business requirements are understood by technical teams

Required qualifications

• Thorough knowledge of GxP and 21 CFR Part 11 regulations and guidelines
• Minimum of 3-5 years' experience as a business analyst in the pharmaceutical or biotech industry
• Experience with regulated system projects, including requirements gathering and deployment
• Excellent organizational skills and ability to present project information effectively
• Capability to multi-task across projects while maintaining attention to detail