13 ago
|
Amerisourcebergen
|
España
13 ago
Amerisourcebergen
España
Quality & Deputy Tech Director (GDP) - Pharma LogisticsApplylocations: If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Job DetailsAlcura is a Cencora-owned company specializing in clinical trial logistics management and healthcare services. They offer customized solutions for pharmaceutical companies, healthcare providers, and patients, including clinical trial management and patient support services.The GDP Deputy Director ensures the safe and compliant distribution of pharmaceutical products and medical devices in line with Good Distribution Practices (GDP) across the supply chain (EU and international).This role is responsible for maintaining a robust quality system, ensuring compliance with regulatory requirements (including AEMPS and EU GDP), and overseeing facilities, processes, documentation, and distribution activities. Ensure compliance with GDP regulations across all operations* Maintain and improve quality assurance systems and SOPs* Manage audits (internal, external,
and regulatory) and inspections* Oversee product recalls, complaints, deviations, and CAPAs* Ensure supplier qualification and regulatory compliance* Monitor storage, transport conditions, and equipment qualification* Manage controlled substances, export/import licenses, and regulatory processes* Support training programs and continuous improvement initiativesQuality Management System:* Collaborate closely with the QA team to investigate customer complaints and deviations related to sourced pharmaceutical products for clinical trials.* Provide relevant information, documentation, and support to facilitate root cause analysis, define corrective and preventive actions (CAPAs), and ensure their effective implementation.* Support actions aimed at preventing recurrence and driving continuous quality improvements.* Requirements:* Degree in Pharmacy* Proven experience in GDP / Quality Manageme
📌 Prácticas Technical Manager Oficinas (España)
🏢 Amerisourcebergen
📍 España