Responsible Person / Felelős Személy (Rp / Qp)

Feladatok: RESPONSIBILITIESAct as the Responsible Person (RP) and Qualified Person (QP) for clinical trial activities in accordance with applicable EU GDP/GMP regulations and local legislation.Provide product oversight for purchasing, inbound receipt, storage, distribution and release of medicinal products used in commercial and clinical trial activities under GDP licensing.Assess, investigate and document incoming product quality, ensuring appropriate handling of damaged, expired or non-conforming products.Ensure an effective Quality Management System is established, maintained and continuously improved in compliance with GDP, GMP, GCP and ISO requirements.Develop, review and approve Standard Operating Procedures (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 CAPA, change control, deviation and risk assessment processes, ensuring timely implementation of corrective and preventive actions.Monitor storage conditions, temperature compliance and product handling activities to ensure full regulatory compliance throughout the supply chain.Ensure compliance with FEFO principles, product segregation, destruction procedures, recalls and product withdrawal activities where required.Review and approve validation and qualification activities related to GDP/GMP operations.Ensure appropriate documentation, traceability and record keeping for all quality-related activities.Deliver GDP/GMP/GxP training and provide ongoing quality guidance to employees and relevant stakeholders.Liaise with competent authorities, marketing authorisation holders, customers and business partners on quality and regulatory matters.Monitor changes in applicable legislation and regulatory requirements, ensuring timely implementation across the organisation.Support continuous improvement initiatives and promote a strong quality culture across the clinical trial logistics operation. Elvárások: RESPONSIBILITIESAct as the Responsible Person (RP) and Qualified Person (QP) for clinical trial activities in accordance with applicable EU GDP/GMP regulations and local legislation.Provide product oversight for purchasing, inbound receipt, storage, distribution and release of medicinal products used in commercial and clinical trial activities under GDP licensing.Assess, investigate and document incoming product quality, ensuring appropriate handling of damaged, expired or non-conforming products.Ensure an effective Quality Management System is established, maintained and continuously improved in compliance with GDP, GMP, GCP and ISO requirements.Develop, review and approve Standard Operating Procedures (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 CAPA, change control, deviation and risk assessment processes, ensuring timely implementation of corrective and preventive actions.Monitor storage conditions, temperature compliance and product handling activities to ensure full regulatory compliance throughout the supply chain.Ensure compliance with FEFO principles, product segregation, destruction procedures, recalls and product withdrawal activities where required.Review and approve validation and qualification activities related to GDP/GMP operations.Ensure appropriate documentation, traceability and record keeping for all quality-related activities.Deliver GDP/GMP/GxP training and provide ongoing quality guidance to employees and relevant stakeholders.Liaise with competent authorities, marketing authorisation holders, customers and business partners on quality and regulatory matters.Monitor changes in applicable legislation and regulatory requirements, ensuring timely implementation across the organisation.Support continuous improvement initiatives and promote a strong quality culture across the clinical trial logistics operation.Gyógyszerész

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