Eva Czerwiec
Fähigkeiten und Kenntnisse
Werdegang
Berufserfahrung von Eva Czerwiec
- Current 10 years and 4 months, since Feb 2016
Founder and Senior Consultant
Quality and Compliance Consulting GmbH
Founder and Consultant at Quality and Compliance Consulting, GmbH, Zurich, Switzerland. Experienced in Quality Systems (QA and QC), Regulatory Affairs, Remediation projects, Project Management and Production/Manufacturing Support with 10+ years international experience in Quality and Regulatory Affairs in the biopharma/pharma and in vitro diagnostics (medical devices) industry.
- 10 months, Dec 2014 - Sep 2015
QA, Associate Director
UCB Pharma
- QA Production Support for the Biologics Plant - Lead on compliance improvement projects (e.g. Master Batch Record project, internal audits, raw material risk analysis project) - QA release of raw materials - Review of Master Batch Records and executed Batch Records (to assist QP in release of the batches)
- Development of validation strategy, protocols and reports (QC methods, Excel sheets). - Development of compliance improvement strategy
- 1 year and 1 month, Jun 2012 - Jun 2013
Sr QC Scientist (Associate Director level)
ImClone Systems LLC; A wholly-owned subsidiary of Eli Lilly and Company
QC liaison and author/editor for (global) regulatory submissions including CMC/Module 3 sections of BLA/MAA dossiers and IND, IMPD, APR, DSUR dossiers. Technical reviewer for documents (SOP’s, Protocols, Reports, Policies) Project manager global method transfers. Technical SME QC methods. QC representative in cross-functional and cross-departmental teams.
- 1 year and 6 months, Jan 2011 - Jun 2012
QC Manager
ImClone Systems LLC; A wholly-owned subsidiary of Eli Lilly and Company
Manager of 2 QC labs responsible for release, stability and in-process testing 5 direct reports (14-16 total reports, Bachelor, Master, PhD) Project manager global method transfers SME method validations using DOE QC representative in cross-functional and cross-departmental teams
- 1 year and 4 months, Jun 2009 - Sep 2010
Manager QC/QC Project Specialist
Lonza Biologics Incorporated
Manager of the QC Laboratory Support Group 3-4 direct reports (Bachelor, Master, High School) QC data management, cGMP documentation and compliance QC Project Specialist: Client project evaluation and budgeting Operational excellence lead
- 2 years and 6 months, Dec 2006 - May 2009
QC Manager/QC Scientist III
ImClone Systems Corporation; A wholly-owned subsidiary of Eli Lilly and Company
Project manager/ business analyst LIMS inception and implementation project Chair QC Project Review Team Budget management (capital and expense) Investigations, CAPA’s, change controls QC member of cross-functional teams Subject Matter Expert for regulatory inspections
Ausbildung von Eva Czerwiec
- 9 years and 9 months, Oct 1986 - Jun 1996
Applied Biological Sciences
University of Brussels (VUB)
G-protein coupled neurotransmitter receptors, protein biochemistry
- 3 years, Oct 1982 - Sep 1985
Chemical Engineering - Biotechnology
University of Brussels (VUB)
Biotechnology
- 1 year and 10 months, Oct 1980 - Jul 1982
Biology
University of Brussels (VUB)
- 2 years, Oct 1980 - Sep 1982
Agronomy
University of Brussels (VUB)
Sprachen
English
C1 (Fließend)
French
C1 (Fließend)
German
A1-A2 (Grundkenntnisse)
Dutch
C2 (Verhandlungssicher / Muttersprachlich)
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