Archive Manager

About the job

• 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 archiving system UnIS for archiving and managing 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 of local standard operating procedures (SOPs) and work instructions (WIs) and support with deviations and changes of the central archive
• Continuous improvement and harmonisation of processes and systems in collaboration with various interfaces and customers

• 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 the GMP-regulated environment, experience in implementing improvement initiatives
• Experience in creating/adapting SOPs, work instructions (WIs) as well as basic knowledge in deviation management
• High customer orientation as well as independent, precise working style and IT affinity are essential
• Knowledge of Excel
• Willingness to perform light to moderate physical work (packing boxes for internal shipping and to the external archive provider and sorting folders on shelves)
• Very good communication skills in German (spoken and written), English skills are an advantage