Dr. Rafal Maksym
Bis 2022, Quality Systems & Validation - Change Control, Roche Diagnostics GmbH Deutschland, Penzberg
Abschluss: PhD in Biochemistry, Ludwig-Maximilians-Universität München
Munich, Deutschland
Werdegang
Berufserfahrung von Rafal Maksym
Bis heute 2 Jahre und 3 Monate, seit März 2022
Validation Manager
Boehringer Ingelheim, Biberach
2 Jahre und 2 Monate, 2020 - Feb. 2022
Quality Systems & Validation - Change Control
Roche Diagnostics GmbH Deutschland, Penzberg
2018 - 2020
Validation Specialist / Consultant
PQE Deutschland GmbH
- Prospective and retrospective validation of computerized systems - Assessment of compliance to GxP (CFR21 Part11, EU cGMP Annex 11) - GxP Risk Assessment - Electronic Records re-qualification - Data migration - Preparation of SOPs - Main customers: CSL Behring, Mylan, Roche
2016 - 2017
Life Science Management Seminar
ATV Ausbildung Training Vernetzung GmbH
Professional Training in Life Science Management. Main subjects: - Pharma-Management: Quality Management, Regulatory Affairs, Clinical Studies - Project Management - Team Leadership, Self Management
- PhD in Biochemistry - Planning and execution of research projects related to analytics, metabolomics and regulation of gene expression - Dissertation: "Arabidopsis small molecule glucosyltransferase UGT76B1 conjugates both ILA and SA and is essential for the root-driven control of defense marker genes in leaves"
1 Jahr und 9 Monate, Jan. 2010 - Sep. 2011
Research assistant
Institute of Bioorganic Chemistry Polish Academy of Sciences (IBCH PAS)
- Project: “Elaboration of an innovative technology for RNA synthesis and RNA microarrays construction” - Design, preparation and validation of microarrays
1 Jahr und 3 Monate, Okt. 2008 - Dez. 2009
Research Assistant (Master Thesis Project)
Institute of Bioorganic Chemistry Polish Academy of Sciences (IBCH PAS)
- Master thesis on “Changes inducted by abiotic stress in Nicotiana tabacum transcriptome – studies involving cross species hybridization” - Participation in a new method development to monitor transcritptional changes in tobacco by the use of tomato microarray
2 Monate, Juli 2008 - Aug. 2008
Internship
University of Natural Resources and Life Sciences (BOKU) Vienna
Support by microbial inhibition tests and microbes identification.
10 Monate, Apr. 2007 - Jan. 2008
Internship
Center of Excellence for Nucleic Acid-based Technologies,IBCH PAS
General support in biochemistry laboratory.
Ausbildung von Rafal Maksym
2011 - 2016
Biochemistry
Ludwig-Maximilians-Universität München
6 Monate, Feb. 2008 - Juli 2008
Biotechnology
University of Natural Resources and Life Sciences, Vienna (BOKU)
Socrates/Erasmus Scholarship
5 Jahre und 3 Monate, Okt. 2004 - Dez. 2009
Biotechnology
Poznań University of Life Sciences, Poland
Sprachen
Polnisch
Muttersprache
Englisch
Fließend
Deutsch
Fließend