Packaging Specialist

vor 2 Wochen

Marburg an der Lahn, Hessen, Deutschland OSB AG Vollzeit
Job Description

Be part of a dynamic team at OSB AG and take on the challenge of ensuring the smooth planning and coordination of labeling, packaging, and release of investigational medicinal products for global clinical programs.

Key Responsibilities
  • Plan and coordinate labeling, packaging, and release of investigational medicinal products for global clinical programs, including Investigator Initiated Trials (IITs)
  • Ensure regulatory compliance in IMP label text translations and provide consultancy to CTS study teams on packaging
  • Manage material master data, packaging plans, and demand for packaging components, while overseeing SAP-based packaging orders and coordinating test sample supplies
  • Ensure compliance with country-specific regulations by generating and maintaining study-specific label text and coordinating label printing
  • Support global departments in IITs by consulting on packaging design, managing supply concepts, and coordinating the delivery of packaged products
  • Oversee quality aspects such as SOP development, change management processes, and contributing to audits and inspections
  • Lead meetings with global CTS study teams and external providers to define packaging and labeling strategies, and participate in relevant study team and CTS meetings
Requirements
  • University Degree in Logistics or Economics or relevant professional experience
  • Very good knowledge of clinical supply packaging processes, in GMP, GDP, and GCP regulations
  • Familiarity with international regulations regarding labeling of investigational medicinal products
  • Ability to work in a matrix structure
  • Fluent English language skills
What We Offer
  • Permanent Employment
  • Attractive Salary
  • Mobile working in consultation
  • Individual Trainings
  • Flexible Working Hours
  • Employee Events
  • Wellpass

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