Archive Manager

Archive Manager
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Roche Schweiz bridges the gap between pharmaceuticals and diagnostics. Important research and development functions are located here. For our long-standing client, F. Hoffmann - La Roche AG in Kaiseraugst, we are looking for an

Archive Manager
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Background:
Within Drug Product Manufacturing KAU/BS, Engineering and SHE (Safety, Health and Environment) operate a central archive, which is responsible for the management of physical documents. This includes receiving documents from various production units and support functions, subsequent storage in the on-site archive, as well as outsourcing to an external archive.

Tasks & Responsibilities:

• Management of the central archive for the Drug Product Manufacturing KAU/BS site, including GMP-compliant management, filing, and archiving of documents
• Ensuring and monitoring GMP standards according to regulatory and internal requirements as well as COREMAP guidelines
• Use of the UnIS archiving system for the archiving and management of documents
• Ensuring the destruction process at the end of the specified retention period
• Coordination of the outsourcing of archived documents to the external archive provider
• Participation in adjustments to local Standard Operating Procedures (SOPs) and Work Instructions (WIs) and support with deviations and changes of the central archive
• Continuous improvement and harmonization of processes and systems in cooperation with various interfaces and customers

Must Haves:

• Commercial, technical, or scientific training or many years of professional experience in archiving or documentation processes (at least 5 years)
• Preferably 2 years of experience in the pharmaceutical industry and in a GMP-regulated environment, experience in the implementation of improvement initiatives
• Experience in the creation/adjustment of SOPs, Work Instructions (WIs) as well as basic knowledge in deviation management.
• High customer orientation as well as independent, precise way of working and IT affinity are essential
• Knowledge of Excel
• Willingness to perform light to moderate physical work (packing boxes for internal shipment and to the external archive provider and sorting files into the shelves)
• Very good communication skills in German (oral and written), English skills are an advantage

What is offered to you:

• A chance to contribute to one of the most significant pharmaceutical companies in the world
• Modern campus with lots of green spaces and meeting zones
• Varied activity profile
• Further training opportunities through temptraining
• Collaboration in a dynamic and motivated team

You are welcome to send your complete application documents to Frau Marianne Buser.

Basel Basel-Land Aargau GMP Archivierung Dokumentationsprozesse Prozessoptimierung Deviations Management SOP's