Quality Specialist, Hungary

At Oximio, we help accelerate clinical research by delivering reliable clinical trial logistics solutions across the globe.

We are looking for a Quality Specialist to support our local and global quality activities and ensure that our operations comply with applicable quality standards, procedures, GxP requirements and legislation.

This is a hybrid position, combining home-based work with occasional presence at our Hungary site.

Reporting to the Senior Regional Quality Manager , you will play a key role in maintaining and continuously improving the Quality Management System for our Hungary operations.

You will:

- Implement and maintain Quality Assurance processes, procedures and standards locally.
- Maintain and improve the local Quality Management System (QMS) and related documentation.
- Ensure warehouse operations comply with applicable SOPs, Work Instructions, ISO 9001, GxP and regulatory requirements.
- Develop, review and communicate SOPs, Work Instructions and other quality documentation.
- Deliver QMS, GxP and onboarding training and support training compliance.
- Plan and conduct internal and supplier audits, support client and external audits, and follow up on audit findings.
- Lead and support non-conformity investigations and CAPA activities, ensuring timely and effective closure.
- Participate in Management Reviews, risk assessments and change control activities.
- Support the implementation and continual improvement of the Environmental Management System (EMS).
- Identify opportunities for quality improvement and provide recommendations to management.

Requirements

- Higher education degree in a relevant field.
- Minimum 3 years of Quality Assurance experience, preferably in pharmaceutical logistics, clinical research or another regulated environment.
- Experience working with Quality Management Systems, GxP, SOPs, CAPA and audits.
- Experience working in a global, multi-site and multicultural organisation is an advantage.
- Excellent written and spoken English.
- Good knowledge of Microsoft Excel, Word and PowerPoint.
- Strong communication and stakeholder management skills, with the ability to work effectively with colleagues, clients, vendors and suppliers.

Benefits

- Join a growing international company supporting clinical research worldwide.
- Gain exposure to Quality Assurance, GxP, audits and Quality Management Systems within clinical trial logistics.
- Opportunities for professional development and continuous learning.
- A collaborative, supportive and purpose-driven working environment.