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LIMS CSV Experte (w/m/d) / LIMS CSV Expert (f/m/d)

Singen (Hohentwiel), Germany

Overview

Every day, employees working in Takeda’s Global Manufacturing and Supply Chain, and Global Quality business unit are shaping the future of healthcare. They are breaking down barriers and ensuring our life-changing medicines are available, accessible, and affordable to patients. Life-changing for you. Life-changing for patients.

Global Manufacturing and Supply Chain, and Global Quality is the backbone of Takeda, and our employees are the guardians for our patients, our products, and our reputation. As a member of our team, we can offer you the opportunity to grow in a meaningful career, develop your skills, and come to work every day knowing that what you do makes a genuine difference.

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Success

What makes a successful member of our team? Check out the traits we’re looking for and see if you have the right mix.

  • Agile
  • Ambitious
  • Analytical
  • Collaborative
  • Enthusiastic
  • Entrepreneurial

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Opportunity

  • Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.

  • Here, you will feel welcomed, respected, and valued as a vital contributor our global team.

  • Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

  • A strong, borderless team, we strive together towards our priorities and inspiring mission.

  • Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2018.

  • Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.

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LIMS CSV Experte (w/m/d) / LIMS CSV Expert (f/m/d)

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Job ID R0012578 Date posted 09/23/2019 Location Singen (Hohentwiel), Germany

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Job Description

For English see below.

Ihre Aufgaben

  • Sie unterstützen operativ die Validierung des LIMS-Systems insbesondere bezüglich Änderungsmanagement, Benutzeranforderungen, Risikomanagement und Benutzerakzeptanztests
  • Sie unterstützen und treiben die Validierung von LIMS-Schnittstellen voran
  • Festlegung von Standards für Customization, Konfiguration und Master Data Management
  • Unterstützung und Weiterentwicklung des LIMS im Hinblick auf Umgebungs- und Wasser-Monitoring einschließlich der entsprechenden Trending-Tools
  • Verbesserung des Change- und Incident Managements des LIMS zur kontinuierlichen Aufrechterhaltung des Validierungsstatus
  • Unterstützung von Prozessoptimierungen, z.B. durch die Nutzung des LIMS zur Etablierung eines „Papierlosen Labors“

Ihr Profil

  • Abgeschlossene Ausbildung oder abgeschlossenes Studium in Naturwissenschaften oder Informationstechnologie
  • Mindestens 3 Jahre Berufserfahrung in der Pharmaindustrie
  • Ausgezeichnete CSV-Kenntnisse und Erfahrungen, einschließlich Kenntnisse der aktuellen CSV- und Datenintegritätsstandards.
  • Erfahrung mit LIMS-Systemen, vorzugsweise Labware LIMS
  • SehrguteEnglischkenntnisse
  • Fundierte IT-Kenntnisse
  • Ausgeprägte analytische Fähigkeiten
  • Teamfähigkeit und Aufgeschlossenheit
  • Ein hohes Maß an Motivation und Durchsetzungsvermögen

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YourAccountabilites

  • Support and drive validation of the LIMS system concerning the Business part of Validation: Change Management, User Requirements, Risk Management and Performance Qualification
  • Support and drive validation of LIMS interfaces.
  • Establish practical standards for customization, configuration and master data management
  • Support and drive LIMS-enhancements like Environmental Monitoring and Water Monitoring including respective trending tools
  • Improve change and incident management of LIMS to sustain validated state
  • Support process optimizations, e.g. by enabling LIMS to support paperless lab

The personshouldhave

  • An educational background in natural sciences or Information Technology
  • Professional experience in the pharmaceutical industry for at least 3 years
  • Excellent CSV knowledge and experience, including knowledge of current CSV and data integrity standards.
  • Professional experience with LIMS systems, preferable Labware LIMS
  • Fluid English language skills
  • Good analytical and social skills
  • Team player, and open minded
  • Assertiveness
  • Being highly motivated and team oriented

Takeda GmbH

Human Resources Germany

Robert-Bosch-Straße 8, 78224 Singen
Tel.: +49 7531-84 2108

germany.jobs@takeda.com
http://www.takeda.com/de-de/

Locations

Singen, Germany

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0012578

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