Overview
Quality Assurrance Associate Jobs in Budapest, Hungary at HungaroTrial CRO
Title: Quality Assurrance Associate
Company: HungaroTrial CRO
Location: Budapest, Hungary
HungaroTrial is the largest regional CRO in Central and Eastern Europe with 10 offices in the region and USA, plus Business Development office in London, UK and Korea.
The Quality Assurance Associate supports the implementation and maintenance of quality systems to ensure clinical trial activities are conducted in compliance with ICH-GCP, applicable regulatory requirements, sponsor expectations, and internal SOPs. The QA Associate will coordinate and collaborate with cross-functional teams to implement quality processes, conduct audits, monitor compliance, and drive continuous improvement by working closely with Clinical Operations, Regulatory Affairs, Human Resources, and other cross-functional teams throughout the clinical trial lifecycle.
KEY RESPONSIBILITIES
- Support the execution and maintenance of the Electronic Quality Management System (eQMS) for GCP-regulated clinical trials.
- Monitor compliance with ICH-GCP, FDA, EMA, and applicable regulatory requirements.
- Ensure clinical trial processes prioritize subject safety, data integrity, and protocol adherence.
- Review QMS documentation including manuals, policies, SOPs, WIs, Forms & templates and reports for GCP compliance.
- Assist QAM and QAD to eQMS management and quality checks to ensure completeness, accuracy, and inspection readiness.
- Assist with document control and version management activities.
- Participate in internal and external audits and support vendor, site, process, office audits etc. and maintain Internal and External Audit trackers.
- Document audit observations and assist in root cause analysis.
- Support the development, tracking, and closure of Corrective and Preventive Actions (CAPAs) and maintain a CAPA tracker.
- Follow up on CAPA effectiveness to ensure sustained compliance.
- Work closely with Clinical Operations, Regulatory Affairs, and Medical teams to ensure quality is embedded throughout trial execution.
- Support issue escalation and resolution related to compliance risks.
- Assist in preparation for regulatory inspections (FDA, EMA, and other health authorities).
- Support inspection documentation, responses, and follow-up actions.
- Maintain quality metrics and prepare summary reports for QAM/QAD.
- Identify trends, recurring issues, and opportunities for quality and process improvement.
- Contribute to initiatives that enhance efficiency, reduce compliance risk, and strengthen GCP practices.
- Perform any additional responsibilities allocated by QAM/QAD as required.
REQUIRED QUALIFICATIONS
Experience
- 0–2 years of experience within a GCP-regulated environment.
- experience in a Clinical Research Associate position
Education
- Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Clinical Research, or a related discipline.
Technical & Regulatory Knowledge
- Working knowledge of ICH-GCP (E6), FDA regulations, and EMA guidelines is preferred.
- Proficiency in MS Office (Word, Excel, PowerPoint).
Other:
- Confident IT skills;
- Professional level of English
- Effective communication, customer focus, teamwork, time management, motivation to learn and develop
