Ulf Hüne

Freelance Consultant at GMP Healthcare Ltd
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Contact Information
us****@****om
(386) 825-5501
Location
Göttingen, Lower Saxony, Germany, DE

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Bio

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Experience

  • GMP Healthcare Ltd
    • United Kingdom
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Freelance Consultant
      • Feb 2023 - Present

      -GMP-Troubleshooter; -Deviation Manager; -CAPA-manager; -Change-manager; -OOX analysis of the last 3years; -Deviation analysis for a FDA-response; -QP-support; -QA-support; -Termination of contracts (QAAs, Supplier contracts). -GMP-Troubleshooter; -Deviation Manager; -CAPA-manager; -Change-manager; -OOX analysis of the last 3years; -Deviation analysis for a FDA-response; -QP-support; -QA-support; -Termination of contracts (QAAs, Supplier contracts).

  • Freiberuflich
    • QM-Beratung für GMP und ISO 9001, sowie ISO 13485
      • Aug 2019 - Present

      Quality Specialist for GMP and ISO9001 Consultant Troubleshooter Teamplayer (American Football, defensive lineman-noseguard #54-retired) Quality Specialist for GMP and ISO9001 Consultant Troubleshooter Teamplayer (American Football, defensive lineman-noseguard #54-retired)

  • TempSearch GmbH
    • Germany
    • Business Consulting and Services
    • 1 - 100 Employee
    • Consultant
      • Nov 2022 - Nov 2022

      Consultant at WuXi in Wuppertal. Consultant at WuXi in Wuppertal.

  • Johnson & Johnson Surgical Vision
    • Groningen, Niederlande
    • QA Officer Engineering
      • Jan 2022 - Jun 2022

  • Lonza Netherlands, former PharmaCell
    • Netherlands
    • Pharmaceutical Manufacturing
    • 100 - 200 Employee
    • Senior Quality Engineer
      • Oct 2021 - Dec 2021

  • Juno Therapeutics, Inc.
    • United States
    • Biotechnology Research
    • 1 - 100 Employee
    • Quality Assurance Associate
      • May 2016 - Oct 2016

      GMP-readiness implementation Aufbau eines Q-Systems Harmonisierung mit dem US-Mutterkonzern Implementation von QS-Tools und SOPs: Q-System, Dokumentenmanagement, CAPA, Change, Deviation, Validation, Training GMP-readiness implementation Aufbau eines Q-Systems Harmonisierung mit dem US-Mutterkonzern Implementation von QS-Tools und SOPs: Q-System, Dokumentenmanagement, CAPA, Change, Deviation, Validation, Training

  • Lomapharm GmbH
    • Germany
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Quality Assurance Specialist und QMB
      • Jan 2012 - Apr 2013

      Erhöhung der GMP-Compliance Zertifizierung ISO 9001 Zertifizierung ISO 13485 Audits: FDA, Behörde, Kunde, interne Audits Erhöhung der GMP-Compliance Zertifizierung ISO 9001 Zertifizierung ISO 13485 Audits: FDA, Behörde, Kunde, interne Audits

Education

  • Otto-Hahn-Gymnasium Göttingen
    Abitur
  • Georg-August-Universität Göttingen
    Diplom-Biologe (Uni), Diplom-Biologie

Community

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