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Our Team:

GDPU Lab Operations Frankfurt is responsible for Development and GxP testing, test data documentation and test room incl, equipment. Our labs are handling and testing: pen, large volume devices, syringes, safety systems, autoinjectors and packaging.

Main responsibilities:

• Accountable for handling of drug device combination products, medical devices and their components as well as packaging and label materials. Aimed to provide them for engineering testing, design verification, process development testing and assembly campaigns in all GDPU labs and at external supplier facilities.
• Accountable to manage pharmaceutical products throughout their lifetime in the lab, which covers sample reception, relocation and transfer, preparation and labelling for tracking purposes, booking and withdrawal of samples and disposal.
• Responsible for inventory and shipping of Zwick machine spare parts to provide immediate support for Zwick cluster machines in the worldwide M&S QC and lab network.
• Responsible for proper documentation of all sample movement with adherence to internal procedures and GxP, especially GDP and GLP.
• Ensure collaboration with third parties for transport and storage of samples to be in accordance with internal procedures.
• Transport and/or ship samples with adherence to internal procedures.
• Transport and/ or ship samples outside EU and oversee required tax and customs processes.
• Organize/conduct training on sample handling for internal and external lab personnel.
• Author and review internal and external documentation for sample handling procedures.
• Responsible for availability for use for laboratory Infrastructure.
• Responsible for operating the environmental monitoring systems in GDPU labs and specifically at the sample storage area.
• Author / review temperature and humidity monitoring reports in GDDL.
• Accountable to establishment of LIMS-based sample handling in other GDPU labs, including creating of meaningful nomenclature of samples and technology implementation.
• Interface to global LIMS teams for all questions relating ongoing support/usage of LIMS system and alignment on future adaptions for LIMS.
• Maintain a stock of commonly used lab consumables and ship at ad-hoc request to other labs in the M&S QC and lab network to ensure continuous testing capability.
• Responsible for implementing and maintaining KAIZEN/5S standards in GDPU laboratories including training of employees.

About you

Qualification and Experience:

• Master´s degree in a technical, logistical or natural science related area 
• strong knowledge about GxP lab processes, experienced in logistics processes

Soft skills:

• well structured, excellent communication skills, striving for efficiency

Technical skills:

• technical knowledge regarding inventory and LIMS systems

Languages:

• English mandatory, German and French are a plus

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