(m/f)

About the role

We are looking for a Responsible Person (RP) to ensure the implementation, maintenance and continuous improvement of the Good Distribution Practice (GDP) Quality Management System in accordance with EU GDP Guidelines and national regulatory requirements. This is a key position responsible for ensuring GDP compliance throughout wholesale distribution activities and safeguarding the quality, integrity and traceability of medicinal products across the supply chain.

Key responsibilities

• Establishing, maintaining and continuously improving the Good Distribution Practice (GDP) Quality Management System
• Developing, reviewing and maintaining GDP procedures, the Quality Manual, Management Reviews and quality documentation
• Managing authorised wholesale distribution activities and ensuring the accuracy and integrity of GDP records
• Ensuring implementation and maintenance of initial and continuous GDP training programmes
• Coordinating and managing medicinal product recalls
• Ensuring the effective handling of customer complaints
• Approving and periodically evaluating suppliers and customers
• Approving subcontracted activities that may impact GDP compliance
• Maintaining records of delegated responsibilities
• Deciding on the final disposition of returned, rejected, recalled and falsified medicinal products
• Approving the return of medicinal products to saleable stock where appropriate
• Overseeing the receipt, storage, distribution and transportation of medicinal products, ensuring full traceability
• Ensuring compliance with additional national requirements applicable to specific medicinal products
• Managing GDP change control, Quality Risk Management (QRM) and deviation management
• Planning and conducting self-inspections and supplier audits, including oversight of CAPA implementation
• Preparing regulatory documentation and applications relating to wholesale distribution authorisations

Requirements

• Master’s degree in Pharmacy or an equivalent qualification in accordance with applicable legislation
• Minimum 1 year of experience in pharmaceutical quality assurance, wholesale distribution or Good Distribution Practice (GDP)
• Good knowledge of EU Good Distribution Practice (GDP) Guidelines and pharmaceutical Quality Management Systems
• Fluency in English; working knowledge of Slovenian
• High level of responsibility, independence and attention to detail
• Strong organisational and decision-making skills
• Willingness to ensure 24/7 availability as required for the Responsible Person (RP) role

We offer

• A key expert role with significant responsibility for GDP compliance and medicinal product quality
• A professional, regulated and internationally oriented working environment
• Participation in quality, regulatory and continuous improvement projects
• Opportunities for continuous professional development
• Collaboration with multidisciplinary teams in the pharmaceutical supply chain
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If you are motivated by a high-responsibility role in Good Distribution Practice and wish to contribute to maintaining the quality and integrity of medicinal products, we invite you to submit your application with your CV.