It Business Analyst For Edms/qms

GALDERMA AUSTRALIA

Krakow, Poland
Hybrid
Edms and qms solutions
Gxp, iso, 21 cfr part 11 compliance
Requirements gathering and process mapping
This senior role will play a key part in shaping and optimizing our electronic Document Management Systems (eDMS) and Quality Management Systems (QMS), ensuring they effectively support business needs while meeting stringent regulatory and compliance standards

Job Summary

  • This senior role will play a key part in shaping and optimizing our electronic Document Management Systems (eDMS) and Quality Management Systems (QMS), ensuring they effectively support business needs while meeting stringent regulatory and compliance standards.
  • As a trusted partner to Quality, Regulatory, and IT stakeholders, you will translate complex business requirements into robust, compliant digital solutions that support document lifecycle management, quality control, and audit readiness.
  • You will be working for an organization that embraces diversity & inclusion and believe we will deliver better outcomes by reflecting the perspectives of our diverse customer base.

Matching Summary

This senior role will play a key part in shaping and optimizing our electronic Document Management Systems (eDMS) and Quality Management Systems (QMS), ensuring they effectively support business needs while meeting stringent regulatory and compliance standards.

Skills & Requirements

Must-have

  • eDMS and QMS solutions
  • GxP, ISO, 21 CFR Part 11 compliance
  • requirements gathering and process mapping
  • system validation activities
  • stakeholder partnership and governance
  • Fluent English, written and spoken

Nice-to-have

  • positive energy and collaboration
  • passion for meaningful work
  • personal growth and empowerment
  • embracing diversity and inclusion

Key Requirements

  • Significant experience as an IT Business Analyst
  • Experience with eDMS and/or QMS in regulated industries
  • Hands-on experience with platforms like OpenText, Veeva Vault, MasterControl or TrackWise
  • Experience managing vendors and cross-functional stakeholders

Work Rights

Not specified

Tailored Resume

Cover Letter