Dr. Karina Schwebe
Angestellt, Head of Quality Assurance, Galexis AG
Basel, Schweiz
Über mich
I'm a resilient person with a strong regulation and process-oriented mind set and a high capability of managing complexity and solving problems. My curiosity and permanent willingness to extend my expertise and my improvement driven personality allows me to establish lean and sustainable systems and processes while using pragmatic approaches. Beside focussing on local requirements, I love being part of a global team with cross county and department collaborations and projects.
Werdegang
Berufserfahrung von Karina Schwebe
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