Nina Pitz - CAPA Manager Encapsulation Department (Competence Center Kreon)
Experience
CAPA Manager Encapsulation Department (Competence Center Kreon)
Abbott Laboratories
- Planning, implementation and documentation of root cause analyses, CAPA actions and deviation reports in close cooperation with customers
- Presentations for audits
- Training of employees
- Reviewing all batch documentation and ensuring GMP conformity and overall compliance in close cooperation with the quality department
Team Lead (Cleaning Center)
Abbott Laboratories
- Leading the cleaning center: cleaning, sterilizing and providing glassware and lab equipment for sterile assay production
- Personnel responsibility for 10 employees
- Project responsibility, e.g. qualification of new equipment, process validations, writing SOPs and risk analyses
Project Lead (Project Management Office)
Abbott Laboratories
- Managing a site-wide project portfolio of about 60 projects
- Leading best practice workshops and training sessions
- Project lead for a development and engineering project with a project budget of €500,000
Student and Research Assistant
Institute for Industrial Information Technology
- Support in medical imaging and user interaction
Industry Experience
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Experienced in Healthcare, Pharmaceutical, Education, and Biotechnology.
Business Area Experience
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Experienced in Quality Assurance, Project Management, Information Technology, Research and Development, Production, and Product Development.
Skills
- Very Good Ms Office Skills
- Experience With Sap, Electronic Manufacturing Execution Systems And The Project Management Software Planisware®
- Basic Knowledge Of Matlab, Image J, Adobe Xd, Power Bi
- Basic Knowledge Of C, Java, Sql
- Experience In Quality Management According To Iso 9001 And Good Manufacturing Practice (Gmp)
Languages
Education
IU International University
Master of Business Administration · Business Administration · Germany · 1.9
University of Duisburg-Essen
Master's program · Medical Technology, focus on Biomedical Engineering · Essen, Germany
Technical University of Ostwestfalen-Lippe
Bachelor of Science · Medical and Health Technology · Germany · 1.7
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Experience
Global Experience
Expertise
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Profile
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