Dr. Karina Schwebe
Fähigkeiten und Kenntnisse
Werdegang
Berufserfahrung von Karina Schwebe
- Bis heute 3 Jahre und 3 Monate, seit Mai 2022
Head of Quality Assurance
Galexis AG
- 2 Jahre und 1 Monat, Apr. 2020 - Apr. 2022
Quality Responsible Person/FvP/QP & Responsible Person for Narcotics
Mundipharma Medical Company
responsible person for narcotics and GDP - maintenance of the local quality management system - management of QTAs - batch release to the Swiss market - GxP training of the employees - collaboration with internal and external partners - interfaces to regulatory affairs and supply chain - establishment of lean and sustainable processes - TrackWise super user for management of complaints, changes, deviations, CAPAs - document management by using MasterControl (electronical DMS)
- 9 Monate, Apr. 2020 - Dez. 2020
Pharmacovigilance Responsible Person (PVRP/PVvP)
Mundipharma Medical Company
- Designated responsible person for Pharmacovigilance - Case reporting and follow up of adverse reactions and OSIs - Reconciliation of ICSRs - Annual and induction GVP training - Management of corresponding procedures - Collaboration with external service providers
- 4 Monate, Dez. 2019 - März 2020
Stellv. FvP/Deputy RP
Mundipharma Medical Company
- 4 Monate, Dez. 2019 - März 2020
Deputy of Responsible Person for Quality (FvP/QP), Narcotics & Pharmacovigilance
Mundipharma Medical Company
- Batch release of pharmaceutical products to the Swiss market - Management of complaints - Management of Returns - Annual and induction GDP/GMP training - Case reporting and follow up of adverse reactions and other safety related events - Reconciliation of ICSRs - Annual and induction GVP training - Management of corresponding procedures - Collaboration with external service providers
- Release (deputy QP/FvP) - Change Control (Change Management) - Customer Support (Resp. contact person in QA) - Deviations/CAPA Management/Complaint Management (TrackWise) - Software: SAP, TrackWise, PAS-X, LIMS; Docubridge
- Product Quality Reviews (Team Lead/Coordination/Writing) - Deviations/CAPA Management/Change Control (TrackWise) - Technical Change Control/Equipment Qualification/Serialization - Self inspections (Lead Auditor/Coordination) - Software: SAP, TrackWise, PAS-X, LIMS; Docubridge
- Quality Documentation - Data Maintenance - Laboratory Information Management System (LIMS)
- 4 Jahre und 5 Monate, Mai 2010 - Sep. 2014
Toxicological standby duty
University Medicine Greifswald
- 5 Jahre und 10 Monate, Dez. 2008 - Sep. 2014
PhD student/Research assistent
Department of Pharmacology, University Medicine Greifswald
Ausbildung von Karina Schwebe
- 5 Jahre und 1 Monat, Okt. 2003 - Okt. 2008
Biochemistry
Ernst-Moritz-Arndt-University Greifswald
Protein Expression and Purification, X-ray Christallography, Structure Determination
Sprachen
Deutsch
Muttersprache
Englisch
Fließend
Spanisch
Grundlagen
Russisch
Grundlagen
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