Dr. Anna-Lena Hürter

Angestellt, Senior Life Science Consultant, Kvalito AG
Regensburg, Deutschland

Fähigkeiten und Kenntnisse

Molecularbiology
Qualitymanagement
cGMP
Biotechnology
Quality assurance
Quality Control
Change Control
Data Integrity
Data Mapping
Risk Analysis
Computer System Validation
Scrum
Agile Projectmanagement
Certified Scrum Master
Product Owner
Regulatory Affairs
GxP
SOP
CAPA
Data Privacy
Data Protection
Complaint Management
Audit
Process management
Electrophysiology
Biophysics
Genomics
expert in the laboratory
open-mindedness
Teamplayer
highly motivated
strong communication skills
intercultural competence
ISO 9001:2015
ISO 19011
ISO 13485
IVD 98/79 EG
GDPR
GAMP5
TrackWise
LIMS
SAP

Werdegang

Berufserfahrung von Anna-Lena Hürter

  • Bis heute 3 Jahre und 6 Monate, seit Feb. 2022

    Consultant - Raw Material Implementation - Cell & Gene Therapy

    Roche in Deutschland
  • Bis heute 7 Jahre und 7 Monate, seit Jan. 2018

    Senior Life Science Consultant

    Kvalito AG

  • 3 Jahre und 5 Monate, Aug. 2018 - Dez. 2021

    Consultant - Quality Assurance

    GSK Vaccines

    GSK Vaccines QC Paperless Project: Implementation of Labware 7 and SAP in Quality Control laboratories and production areas for paperless documentation. QA for change control, documents, method implementation and all quality and compliance related questions. Leading the project change control team.

  • 3 Monate, Juni 2018 - Aug. 2018

    Consultant - Validation Project Manager

    Charles River Laboratories

    Computer system validation (CSV) for different lab equipments, QC, EU GMP Annex 11, FDA 21 CFR Part 11, GAMP5, Data Integrity

  • 3 Monate, Jan. 2018 - März 2018

    Consultant - Data Integrity Specialist

    Boehringer Ingelheim

    Data Integrity, Process Interviews, Data Maps (Visio), GAP Assessments, Risk Analysis, CAPA Actions, Departments: Drug Substance Clinical Supply &Transfer

  • 3 Monate, Okt. 2017 - Dez. 2017

    Project Regulatory Affairs, Quality Management

    Nano Repro AG

    Technical Documentation, Product Information for IVD Products SOPs EN ISO 13485, IVD-Guidline 98/79/EG, GMP Complaint Management Registration of products in different markets

  • 5 Jahre, Nov. 2012 - Okt. 2017

    PhD student, research associate

    Julius-Maximilians-Universität Würzburg, Germany

    molecular biology (DNA/RNA isolation, PCR-Techniques, Plasmid preparation, Vector cloning, sequencing), electrophysiology and biophysics (Single/ Double Electrode Voltage Clamp, fluorescent reporter dye), management of research project, giving scientific presentations (english), supervising and teaching students, collaboration with scientists, PhD thesis: Role of Medicago truncatula anion channels in the Arbuscular Mycorrhiza and Root Nodule Symbiosis

  • 4 Monate, März 2017 - Juni 2017

    Sales, Promotion, Translation

    international fairs in germany

    Sales, promotion and translation (english, french) for different international companies at CeBit, Agritechnica, Biotechnica, Hannover Messe, Eurotier, Domotex, Euroblech, Ligna.

  • 4 Monate, Dez. 2016 - März 2017

    Authorised Representative for integrated Management Systems- GMP

    Habmann Aufstiegs Akademie

    professional development programme in Quality Management (DIN EN ISO 9001), Audit (DIN EN ISO 19011), GMP (AMWHV, GMP, FDA), Environmental Management (EMAS/DIN EN ISO 14001), Project Management, Lean Management, Process Management, Training Capability, Change Management

  • 4 Jahre, Okt. 2008 - Sep. 2012

    Sales, Promotion, Translation

    Messe Hannover

    Sales, promotion and translation (english, french) for different international companies at CeBit, Agritechnica, Hannover Messe, Eurotier, Domotex, Euroblech.

Ausbildung von Anna-Lena Hürter

  • 1 Monat, Mai 2018 - Mai 2018

    Pharma and Life Science

    ISPE Training, Barcelona, Spain

    Basic GAMP® 5 Annex 11/ Part 11 Training Course computer system validation, GAMP5, EU GMP Annex 11, FDA 21 CFR part 11

  • 5 Jahre und 1 Monat, Nov. 2012 - Nov. 2017

    Molecularbiology, Electrophysiology, Biophysics

    Julius-Maximilians-Universität Würzburg

  • 4 Monate, Juli 2012 - Okt. 2012

    Biotechnology

    University of Jember, Indonesia

    working in the lab, supervising students, animating indonesian students to speak and improve their english language skills, language course bahasa indonesia, culture exchange

  • 2009 - 2011

    (Plant) Biotechnology

    Gottfried Wilhelm Leibniz Universität Hannover, Germany

    Biotechnology, Molecular Biology, Genomics, Proteomics, Plant Analytics, Lab Specialist, scientific presentations (english)

  • 2006 - 2009

    (Plant) Biotechnology

    Gottfried Wilhelm Leibniz Universität Hannover, Germany

    Biotechnology, Molecular Biology, Plant Genetics, Proteomics, Plant Analytics, Lab Work

Sprachen

  • Deutsch

    Muttersprache

  • Englisch

    Fließend

  • Französisch

    Gut

  • Spanisch

    Grundlagen

  • Indonesisch

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