The proper storage of Investigational Medicinal Products (IMPs), GMP-compliant materials, Master Cell Banks (MCBs), and reference standards is a critical requirement to ensure product quality, integrity, and full traceability throughout their lifecycle. All materials must be stored under strictly controlled and continuously monitored conditions in accordance with applicable EU GMP guidelines, ensuring compliance with defined specifications. Therefore, we are looking for a service provider ensuring robust storage systems, including qualified infrastructure, validated monitoring systems, and comprehensive documentation practices fully compliant with regulatory expectations. Please refer to the tender documents for further details.
The proper storage of Investigational Medicinal Products (IMPs), GMP-compliant materials, Master Cell Banks (MCBs), and reference standards is a critical requirement to ensure product quality, integrity, and full traceability throughout their lifecycle. All materials must be stored under strictly controlled and continuously monitored conditions in accordance with applicable EU GMP guidelines, ensuring compliance with defined specifications. Therefore, we are looking for a service provider ensuring robust storage systems, including qualified infrastructure, validated monitoring systems, and comprehensive documentation practices fully compliant with regulatory expectations. Please refer to the tender documents for further details.
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Nachweis eines zertifizierten ISMS für den gesamten Projektzeitraum.
Sämtliche Kernmitglieder müssen Deutschkenntnisse auf C1-Niveau nachweisen.
Mindestens drei vergleichbare Projekte in Bundes- oder Landesbehörden in den letzten 5 Jahren.