Fresenius Kabi Deutschland GmbH

Maintain an up-to-date knowledge of cGxP regulation and applicable standards (especially in the US and EU) and implement requirements into locally applicable procedures (SOPs, Guiding Documents, Working Instructions, etc) Manage a GMP compliant transition of Programs from development to commercial Manage GMP compliance during Tech Transfer of manufacturing activities of Combination Product by Authoring, reviewing, approving, as applicable, protocols, plans and reports (e. g. Validations). Identify the risks and establish appropriate mitigation plan Manage GMP compliance during Analytical Transfer activities Manage internal and external Change Controls, Deviations, Events, CAPAs, etc., related to Drug Substance, Drug Product and Combination Products Contribute to QM programs and GMP / GDP / MDR compliance activities as appropriate Manage GMP / GDP / MDR quality oversight (qualification, approval, monitoring) of C(D)MOs, Testing Labs, Medical Devices suppliers, packagers and carriers by Planning and executing vendor audits, including monitoring of CAPA progresses till completion, Negotiate, establish and maintain quality agreements Perform Gate Reviews for PPQ readiness On-site presence during critical activities (e. g. PPQ campaign, Tech Transfer, HA inspections) Define KQIs / KCIs, collect data for periodic management review to identify Risks and mitigate Ensure Inspection readiness of internal Production Units and external CMOs