Overview
Quality Assurance Compliance Specialist Jobs in Budapest, Hungary at Carbyne Consulting
Title: Quality Assurance Compliance Specialist
Company: Carbyne Consulting
Location: Budapest, Hungary
A stable, international pharmaceutical manufacturing company is seeking a new Corporate Quality & Compliance Specialist to join its central quality team. The role is key to maintaining global GxP compliance, supporting regulatory inspections, and further developing the group-wide quality management system.
Key Responsibilities
- Global compliance support – providing expert guidance to manufacturing sites and internal projects.
- Preparing for and supporting regulatory inspections (FDA, EMA, etc.).
- Leading audits – planning and conducting internal GxP audits; participating in the corporate auditor program.
- Monitoring regulatory trends and performing gap assessments.
- QMS development – harmonizing global SOPs, processes, and workflows.
- Collecting, analyzing, and reporting compliance KPIs to management.
Requirements
- 5–10 years of pharmaceutical industry experience in QA/Compliance within a manufacturing environment.
- Strong knowledge of cGMP / GxP regulations (FDA 21 CFR, EU GMP Annexes).
- Experience with quality management systems (e.g. TrackWise, SAP, document management systems).
- Manufacturing (Operations) experience is considered an advantage.
- Excellent stakeholder management and communication skills.
What We Offer
- Remote or hybrid working arrangements, depending on your preference.
- A people-centered, transparent company culture with a strong work–life balance.
- The opportunity to participate in global compliance projects and gain lead auditor experience.
- The backing of a stable, internationally recognized pharmaceutical manufacturing company.
If you are interested in the opportunity, please upload your CV or contact me directly!
