• Ensure that processes, documentation and systems are in place and followed to allow effective analytical method transfers for Commercial site-to-site transfers (including CPO testing labs) in close collaboration with QC
• Creation and oversight for review and approval of transfer documentation (e.g. method transfer plans and reports) in the applicable document management systems (i.e. Subway) in close collaboration with the sending and receiving sites
• Preparation and oversight of material and sample shipments required to support analytical method transfers and comparative testing
• Routinely asses test methods and testing monographs and proactively sustain compliance of all analytical transfer activities with current official regulations, pharmacopeias, QM, QD, GOP, STD and SOP relevant for analytical method transfers
• Provide statistics and test results evaluation/reporting to support decision-making during method transfer. Support investigations (OOS/OOE/OOT, deviations) and provide support for troubleshooting, when needed
• Responsibility for the stability program support associated with transfers incl. results evaluation, reporting and trending, if applicable
• Relevant experience in Biologics QC/AS&T or Quality Function with experience in a commercial manufacturing site
• Profound experience in biological and physico-chemical protein analytics incl. Subway and ESOPS knowledge
• Ability to influence people, negotiate and communicate
• Strong project management skills
• Good and proven ability to analyze, evaluate and ensure cGMP compliance with analytical transfer requirements of analytical method transfers incl. HA requirements such as i.e. FDA, ANVISA)
• Fluent English and German (oral and writing)
• You will work in an international environment
Projektdauer: 10 MM++
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