Job Description
Are you a Change Management professional with hands‑on experience in regulated pharma environments? We are sourcing for a Change Coordinator / Change Owner role overseeing GxP‑relevant changes end‑to‑end — from impact assessment through closure.
This is a cross‑functional role at the center of the change lifecycle — working closely with Project Managers, System Owners, QA, Regulatory Affairs, IT, and Validation/Engineering teams.
What you’ll do:
- Plan and govern changes in line with internal procedures and GxP regulations
- Lead change requests through the eQMS (TrackWise / Veeva) and the Change Panel
- Run Change Impact Assessments across systems, validation status, and regulatory commitments
- Define risk mitigation actions and Effectiveness Plans
- Support audits, inspections, and Health Authority submissions
- Drive post‑release actions through to on‑time, compliant closeout