141 60 Huddinge
Eva has over 30 years’ experience in the pharmaceutical industry. Eva has skills in laboratory work, mainly in molecular biology such as ELISA methods, validation of analytical methods, experience in recombinant production such as purification and analysis. She has over five years’ experience of a role as QA specialist. She is highly experienced in qualification of laboratory equipment. Eva is a good organizer and work systematically against targets. She likes to solve problems and have analytical skills. She is both a team player and a maverick.
2018-August—current Astra Zeneca Global Biologics QC Analytical Biochemist
Work in QC with Analytical Tech Transfer
Previous Jobs and assignments
2017-June—2018 June Astra Zeneca Global Biologics Qualification Engineer (assignment via Semcon) Commissioning and Qualification of lab equipment both with and without computerized systems within Biologics Global Operations AstraZeneca, ahead of the performance of the new factory. The assignment has required supplier contacts. Within the assignment, IQ protocol was designed, tests were carried out and report compiled.
2017 may – 2017 June – Pharmadule Quality Manager QC (assignment via Semcon) Assist in designing quality manual with regard to QC (Quality Control) content. Designed instructions (SOP)
2015-april-2017-april QA Specialist/Qualification Manager at Octapharma AB Worked with qualification of lab equipment’s in the project Octapharma ”Capacity 2019”. QA review regulatory documents. Perform self-inspections within the QC laboratories and PCR. Perform Periodic reviews and re qualifications of lab equipment. Involved in the design of the qualification process for lab equipment in the QC lab and production
2015-april-2006 QA specialist at Octapharma AB Worked with deviation handling, CAPA, SOP´s. Taught in basic GMP and Lean tools for instance 5S. QA review regulatory documents Performed Periodic reviews of computerized systems within the QC laboratories. Supervisor of two master thesis. Was responsible for the design of the annual GMP training together with QA department
2006-2002 Laboratory Engineer at Octapharma AB Worked with PCR analysis. Pooled plasma samples using Tecan dilutions robots. Was responsible Project Manager for PCR department’s relocation to new facilities in year 2005.
2002-1982-nov Laboratory Engineer at Biovitrum/Pharmacia/
Worked with assay development mainly ELISA technique. Worked in various research projects in the field of recombinant production.
Supervisor of one bachelor thesis.
1982 jun-1982-okt Laboratory Engineer at Swedish Tobacco Company
Worked with HPLC and GC analysis.
Higher and basic studies
2017 Web Technology 1 7,5hp Linnéuniversitetet
2016 Labour law II 7,5hp Högskolan Väst
2015 Web Design 7,5hp Linnéuniversitetet,
2015 CSS based web design 7,5hp Umeå Universitet
2015 Lean Production 7,5hp BTH
2014 Work Environment in the New Working Life 7,5hp Uppsala Universitet
2013 Labour law I 7,5hp Högskolan Väst
2011 Quality Technology 7,5hp Högskolan Gotland
2004 Introduction to quality system 7,5hp Karolinska Institutet
2005 Quality System 2 7,5hp Mälardalens Högskola
2005 Physiology-an introductory course 7,5hp Karolinska Institutet
1999 Cell Biology 7,5hp Karolinska Institutet
2005 MSc of Medical Science in Biomedical Laboratory Science, 160 p Karolinska Institutet
1998 BSc of Medical Science in Biomedical Laboratory Science, 120p Karolinska Institutet
1982 Biomedical Scientist 100p HälsoHögskolan
Corporate training in short
- Continues GMP training, Semcon, 2017
- XLPM for project leader, Semcon 2017
- Webinar, Periodisk re-kvalificering – vara eller inte vara? Key2Compliance, 2017
- Webinar Validation and use of Excel Spreadsheets in Regulated Environments ,2017
- Bättre psykosocial arbetsmiljö Unionen, 2016
- Continues GMP training Octapharma,2000–2016
- Läkemedelskongressen ,2012,2013,2015,2016
- SARQA Höstmöte, Vårmöte 2005–2017
- GMP-& QS-krav på datorsystem inkl.21CFR Part 11 Key2Compliance, 2016
- Validering och Kvalificering Key2Compliance, 2015
- QA Forum, 2014
- 5S supervisor training, Part Development ,2013
- Lean Introduction, Octapharma,2013
- Omorganisation MBL/LAS I praktiken Unionen, 2012
- BAM Bättre Arbetsmiljö Uionen,2012
- GMP training, John Y Lee, 2011
- IFBLS 26th World Congress, 2004