Oximio is a global logistics service provider supporting clinical research by delivering reliable and high-quality clinical trial logistics solutions worldwide.
Our licensed facility in Törökbálint, Hungary provides GDP and GMP activities, including customs clearance, import-related services, packaging, labeling, storage and distribution of medicinal products.
We are now looking for an experienced Responsible Person / Qualified Person (RP/QP) to join our growing Hungarian team and oversee the quality and regulatory compliance of our pharmaceutical wholesale and clinical trial logistics activities.
- Act as the Responsible Person (RP) and Qualified Person (QP) for applicable pharmaceutical and clinical trial activities in accordance with EU GDP/GMP requirements and local legislation.
- Provide quality oversight of the purchasing, receipt, storage, distribution and release of medicinal products.
- Ensure compliance with applicable GDP, GMP and GxP requirements throughout the pharmaceutical supply chain.
- Assess, investigate and document incoming product quality issues, including damaged, expired or non-conforming products.
- Establish, maintain and continuously improve the Quality Management System in line with GDP, GMP, GCP and ISO requirements.
- Develop, review and approve SOPs, work instructions, quality documentation and quality agreements.
- Plan, conduct and oversee internal self-inspections, supplier and manufacturer audits, and support customer and regulatory authority inspections.
- Lead and oversee CAPA, deviation, change control and risk assessment processes.
- Monitor storage conditions, temperature compliance and product handling activities.
- Ensure appropriate implementation of FEFO, product segregation, destruction, recall and product withdrawal procedures.
- Review and approve validation and qualification activities related to GDP/GMP operations.
- Ensure appropriate documentation, traceability and record keeping for quality-related activities.
- Deliver GDP/GMP/GxP training and provide quality guidance to employees and relevant stakeholders.
- Liaise with competent authorities, customers, Marketing Authorisation Holders and business partners on quality and regulatory matters.
- Monitor changes in applicable legislation and regulatory requirements and ensure their implementation.
- Support continuous improvement initiatives and promote a strong quality culture across the organisation.
Requirements
Benefits
Skills Required
- University degree in Pharmacy or equivalent qualification required for RP/QP appointment under applicable local legislation
- Proven experience working as a Responsible Person within a GDP-regulated pharmaceutical environment
- Proven experience as a Qualified Person under EU GMP regulations
- Strong knowledge of EU GDP, GMP and GxP requirements
- Experience in Quality Management Systems, audits, inspections and regulatory compliance
- Experience in pharmaceutical wholesale activities
- Experience in clinical trial supply or clinical trial logistics
- Strong analytical, organisational and problem-solving skills with excellent attention to detail
- Excellent communication and stakeholder management skills
- Ability to work independently while collaborating effectively with international and cross-functional teams
- Professional proficiency in English, written and spoken
- 5+ years of relevant pharmaceutical or quality experience
What We Do
Oximio provides global clinical trial logistics and tailored supply chain solutions for complex, multinational clinical studies. It supports pharmaceutical and research organizations with project management, storage and distribution, customs clearance, comparator sourcing, biosample management, temperature-controlled handling, and patient-focused delivery. Its worldwide depot and warehouse network enables compliant movement of investigational medicines and trial materials across international markets from planning through final accountability and destruction.
