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Oximio logo

Quality Specialist, Hungary

Oximio
Posted 4 hours ago
🇭🇺Hungary🏢Hybrid📁Engineering & Development
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Job Description 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.

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