Dr. Christina Nophut
Deputy Head of Quality Management at Fresenius Kabi Deutschland GmbH- Claim this Profile
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English Conoscenza professionale completa
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French Conoscenza base
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German Conoscenza madrelingua o bilingue
Topline Score
Bio
Credentials
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GMP auditor / Lead auditor
PTS Training Service -
Certificate "project management compact"
Ludwig-Maximilians-Universität (LMU) München -
Confirmation of participation of the "basic seminar for professional leadership and cooperation"
Ludwig-Maximilians-Universität (LMU) München
Experience
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Fresenius Kabi Deutschland GmbH
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Germany
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Pharmaceutical Manufacturing
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100 - 200 Employee
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Deputy Head of Quality Management
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lug 2020 - - Presente
+ QM contact (communication with global QM department)+ GMP auditor / lead auditor for internal and external audits+ Key contact for electronic quality management system (eQMS TrackWise)+ Approval of deviations, CAPAs, OOLs and OOTs in eQMS (deviation management)+ Change Control management (Generation, processing and/or approval of change controls)+ CAPA management+ Risk Management (according to ICH Q9): FMEA, GMP risk analysis, Ishikawa+ Qualification and validation expert (including Computer System Validation (CSV) according to GAMP5, Annex 11 and Annex 15, EU-GMP guideline)+ Independent generation and processing of standard operating procedures (SOPs)+ Project work+ Employee trainings (GMP, GDocP, TrackWise, qualification, validation, CSV etc.)
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Quality Manager
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giu 2018 - lug 2020
+ Key user and key contact for electronic quality management system (TrackWise)+ Approval of deviations, CAPAs and complaints in eQMS (deviation and complaint management)+ Change Control management (Generation and processing of change controls)+ CAPA management+ Risk management (according to ICH Q9)+ Qualification and validation (including Computer System Validation according to GAMP5, Annex 11 and Annex 15, EU-GMP guideline)+ Processing of recalls+ Independent generation and processing of standard operating procedures (SOPs)+ Data processing, generation of statistics and compilation of key performance indicators+ Project work (i.e. transport validation)+ Support of internal and external audits+ Employee training (GMP, qualification, validation, CSV, TrackWise, GDocP etc.)
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Executive Quality Manager / Project Engineer
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feb 2015 - mag 2018
Qualification of customized systems (automated systems for liquid and aseptic processes):+ Responsible for quality assurance and qualification in the area "automation" in projects in the pharmaceutical industry+ Experienced teamplayer in many international projects in the pharmaceutical industry + Qualification / validation lead of external projects+ Supervision of the qualification process including change management, generation of the relevant qualification documents (traceability matrices, risk analyses (FMEA), VMP, test specifications etc.)+ Communication with the customers and direct contact regarding qualification matters+ Development of test concepts and methods+ Support and consulting of other departments concerning qualification / validation+ Employee trainings
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Training: Life Science Management
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2014 - gen 2015
Training in Pharma-Management + current principles in healthcare laws and policies (AMG, MPG), + planning and execution of clinical trials (monitoring, ICH-GCP), + market authorization of pharmaceuticals and medical products (regulatory affairs), drug safety / pharmacovigilance, + quality management, quality assurance (GLP, GMP)Principles in business administration+ project management+ business administration (company structures, business processes, accounting, controlling)+ marketing (management process, marketing-mix, marketing strategies)Personal training+ self and time management+ rhetoric and presentation skills+ team and leadership training
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Ludwig-Maximilians-Universität München
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Germany
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Higher Education
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700 & Above Employee
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Research Scientist
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2010 - set 2014
PhD thesis in the field of neuroscience (frontotemporal lobar degeneration, lysosomes, autophagy, TMEM106B).Planning and execution of experiments, documentation of data and results, presentation of scientific results in conferences (posters, talk), writing of papersMethods:+ protein biochemistry (Western Blotting, SDS-PAGE, ELISA, Membrane preparations, immunoprecipitations, glycosylation analyses, cathepsinD activity assays)+ cell culture technology (cultivation of human cell lines, establishment of stable cell lines, transfection)+ microscopy (immunofluorescence, life-cell-imaging)+ RNAi+ molecular biology (cloning, PCR, qPCR, site-directed mutagenesis)Further skills:+ Handling of professional image processing software (photoshop, illustrator), statistic software (Graph Pad Prism) and a document preparation system (LateX)+ literature search+ Supervision of trainees+ Establishment of methods (especially in the area of autophagy / lysosomes)
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Internship Trainee
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ago 2008 - feb 2009
+ Commissioning of an LC system (ICS 3000) to analyse the concentration of various carbohydrates in fermentation samples --> Generation of standards --> Optimization of separation methods --> Validation of one separation method --> Generation of a process specification --> Meassurement of samples from current fermentations --> Statistic evaluation of data+ Assistance with cell culture and the operation of small fermenters --> Preculture for fermentation --> Preparation of fermenters --> Sampling and documentation (cell counts, metabolite and osmolarity determination)+ Software skills: --> Chromeleon (chromatography software) --> Biobook (e-Journal) --> Lucullus (process documentation software)
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Helmholtz Munich
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Germany
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Research Services
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700 & Above Employee
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Student Intern
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ago 2006 - ott 2006
+ DNA preparation from mouse tails+ PCR for genotyping, preparation of lymphoid organs of the mouse+ FACS analysis of the lymphoid cells+ MACS preparations for the purification of B cells+ SDS-PAGE and Western Blotting, immunohistochemistry of murine spleen cryo sections+ Cloning+ Literature research+ Data evaluation + DNA preparation from mouse tails+ PCR for genotyping, preparation of lymphoid organs of the mouse+ FACS analysis of the lymphoid cells+ MACS preparations for the purification of B cells+ SDS-PAGE and Western Blotting, immunohistochemistry of murine spleen cryo sections+ Cloning+ Literature research+ Data evaluation
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Education
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2010 - 2016
Ludwig-Maximilians Universität München
Dr. rer. nat., Biochemistry and Molecular Biology -
2007 - 2010
Technische Universität München
Master of Science (M.Sc.), Molecular Biotechnology -
2009 - 2009
Victoria University of Wellington
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2004 - 2007
Technische Universität München
Bachelor of Science (B.Sc.), Molecular Biotechnology
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