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Support the migration of the Design History Files (DHF) into a new eQMS system
Ensure current documentation is complete and compliant
Prepare the documents for the migration and perform the document migration
Ensure the DHF in the...
Manage a portfolio of assigned Medical Device/ Drug Device Combination projects from quality perspective
Quality responsible person for the assigned Design History File portfolio
Support Medical Device Risk Management, through proactive risk...
creation of documents for validation and qualification (following the Novartis IT guidelines)
execution of validation and qualification of new lab equipment (following the Novartis IT guidelines)
installation of software together with vendor...
Responsible for monitoring all quality and compliance aspects at contract manufacturers of Biologic Drug Product batch record review and support batch release (check documents for completeness & correctness)
Perform and evaluate investigations...
Responsible for monitoring all quality and compliance aspects, having quality oversight for purchased API’s and strategically important regulatory starting materials and chemical intermediates supplied into Novartis sites worldwide
Monitoring of material master maintenance process and the bill of materials
Continuous master data monitoring in cooperation with affected departments
Creation of Master Data records in support of Accounts Transfer from other locations to...