Veronika Halász-Manufacturing Lead
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Experience
Manufacturing Lead
GI.HU (Genetic Immunity) Kft.
- Technology and operational leader for R&D and GMP manufacturing and contract manufacturing activities of the product candidate
- Successful screening and selection of CMOs and CDMOs, establishment of workflows
- Completed risk assessments and gap analyses in relation of the production activities
- Acting as key contact point for CMOs, CDMOs and other contractors; managing and leading negotiations
- Analysis of the current technology of the product candidate (drug substance with biotechnological origin, excipient polymer and related nano formulation) and the medical device; technology optimization, critical parameter setting
- Technology related gap- and risk analysis, decision management, project management and prioritization
- Crisis management and solution setup by critical parameter analysis and investigation of critical quality attributes of the processes
- Definition and selection of the related and needed quality control setup (evaluation of QC tests, specification set up according to relevant guidelines)
- GMP related activities: deviation, change control and OOS management, compilation of GMP related documentation (SOP, WI, etc.)
Global RWE Project Manager
Janssen Pharmaceutica NV
- Manage design, analysis, and publication of retrospective studies for holistic overview of therapeutic areas in close cooperation with internal and external stakeholders, RWE team members, key opinion leaders
- Leverage unique data sets (national data and disease registries) for key access needs in Nordic countries and Western/Central Europe
- Development of project management tool and template to cover all project related activities
- Successful competition of numerous studies to support planning and decision-making activities of the global organization
- Cooperate with project initiators to understand research goals and effectively communicate study limitations and results
- Coordinate and participate in RWE studies from initiation, feasibility and internal and external approvals through full protocol development, statistical planning, data mining and analysis until evaluation and dissemination of results (MS project)
- Drive internal and external processes for reviews and approvals
- Act as key contact point for existing partnerships and projects, look for new opportunities and cooperation
- Manage publication of results
Project manager: Global technology transfer expert
Ceva Hungary
- Support and technology transfer of production technologies and related analytical methods of own and affiliate companies (transfer of R&D developed and validated systems to the industrial routine production as well as execute site to site transfers between affiliate companies)
- Optimization of fermentation and virus cultivation related upstream and downstream processes (experimental design, implementation, evaluation, documentation)
- Scaling up, industrialization in accordance with the GMP, assessment of new procedures and equipment
- Risk analysis and statistical evaluation of datasets related to transfers
Scientific sales manager
SOLVO Biotechnology Ltd
- Overall sales activities related to in vitro and in vivo membrane transporter systems in cooperation with the laboratory team
Product and project manager
3DHISTECH Ltd
- Product management and coordination of a histopathological software family
QA Supervisor
GSK Biologicals
- Responsible for the quality assurance issues related to daily tasks of the Pertussis Unit
- Implementation of SAP QM module as key user (creation of SOP and training material, training of users)
QA Supervisor
TEVA Ltd
- Responsible for the quality assurance issues related to daily tasks of the Injection Unit
- QA responsible for a site change procedure
Industry Experience
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Experienced in Pharmaceutical, Biotechnology, Healthcare, and Information Technology.
Business Area Experience
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Experienced in Project Management, Production, Product Development, Quality Assurance, Research and Development, and Sales.
Skills
- Ms Office (Word, Excel, Pp, Teams, Outlook, Copilot Etc.)
- Sap (Basic Skills, Qm Module)
- Jira (User Skills)
- Good Organization And Prioritization Skills
- Advanced Communication And Interpersonal Skills
- Team Player
- Problem Solver
- Self-motivated
- Enthusiastic
- Precise
- Capable Of Adapting To New Situations
Languages
Education
Corvinus University of Budapest
Engineer – economist, post gradual studies · Budapest, Hungary
Budapest University of Technology and Economics
MSc, applied biotechnology · Bioengineering · Budapest, Hungary
Certifications & licenses
Certified Project Manager
TEQUA
Statistics
Experience
Expertise
Qualifications
Profile
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