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QA Specialist Change Management
vor 3 Monaten
At Elanco (NYSE: ELAN) – it all starts with animals
As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We're driven by our vision of ‘Food and Companionship Enriching Life' and our approach to sustainability – the Elanco Healthy Purpose – to advance the health of animals, people, the planet and our enterprise.
At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you'll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.
Making animals' lives better makes life better – join our team today
Elanco Animal Health ist eines der weltweit führenden Tiergesundheitsunternehmen. Wir entwickeln und vertreiben innovative Produkte und Dienstleistungen, um Krankheiten bei Haus- und Nutztieren vorzubeugen und zu behandeln. So schaffen wir einen Mehrwert für Landwirte, Haustierbesitzer, Tierärzte, Stakeholder und die gesamte Gesellschaft. Mit unserer langjährigen Tradition im Bereich Tiergesundheit helfen wir unseren Kunden dabei, die Gesundheit ihrer Tiere zu erhalten und zu verbessern.
Die KVP Pharma + Veterinär Produkte GmbH produziert als Teil des Elanco Animal Health Unternehmens seit mehr als 50Jahren rund 175 verschiedene Arzneimittel. Unsere Produkte, die das gesamte Spektrum der pharmazeutischen Darreichungsformen umfassen, werden weltweit vertrieben.
Wir suchen zum nächstmöglichen Zeitpunkt eine/n QA Specialist Change Management (m/w/d).
Die Stelle ist auf 2 Jahre befristet.
- Verantwortlich für die inhaltliche Bewertung, fachliche Bearbeitung und Koordination, des Prozesses bei lokalen und CMC Änderungsanträgen, sowie Änderungen bei externen Auftraggebern
- Koordination des Erstellungsprozess von qualitäts- und zulassungsrelevanten Dokumenten
- Ansprechpartner für externe Auftraggeber im Bereich des Change Managements
- Prozessverantwortlich für die Verwaltung von Zulassungsdokumenten externer Auftraggeber
- Unterstützung bei der Entwicklung und Umsetzung der kontinuierlichen Verbesserung, sowie Kontrolle des Änderungsmanagementprozesses
- Prozessverantwortung als Computerized Systems Quality Assurance (CSQA) für alle computergestützten Systeme am Standort
- Ansprechpartner bei Kunden- und Behördenaudits
- Abgeschlossenes naturwissenschaftliches Bachelor- oder Master-Studium, Apotheker (m/w/d) oder eine vergleichbare Qualifikation
- erste Erfahrungen in der pharmazeutischen Industrie und im Qualitätsmanagement wünschenswert
- Kenntnisse der GMP-Regularien erforderlich
- Ausgeprägtes analytisches Denkvermögen
- Hohes Maß an Eigeninitiative, Belastbarkeit, Einsatzbereitschaft und Verantwortungsbewusstsein
- Gute Kommunikations- und Integrationsfähigkeit verbunden mit hoher Sozialkompetenz insbesondere auch im Umgang mit externen Partnern
- Freude an der Arbeit im Team
- Fließende Englischkenntnisse in Wort und Schrift
- Attraktive Vergütung gemäß Tarifvertrag MTV Chemie
- Zahlung einer tariflichen Jahresprämie, Urlaubsgeld und Zahlung eines Zukunftsbetrags – wahlweise in Freistellung oder Entgelt
- Bezuschussung der Altersvorsorge durch den Arbeitgeber
- 37,5 Stunden / Woche
- 30 Tage Urlaub
- Gesundheits- und Fitnessangebote
- Freiraum für Eigeninitiative und Möglichkeiten von individuellen Weiterbildungsmöglichkeiten
- Arbeit in einem dynamischen Team in einem internationalen Unternehmen
Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status
