EVA LAGERHOLM

Eva Lagerholm

Musseronvägen 23

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.

 

Current job

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/

                                                          Pharmacia&Upjohn/KabiGen

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.

Education

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