Computerized Systems Owner (f/m/d)
Vienna, ViennaAt Takeda, Quality has always been a priority for us, throughout our long history. Today, what we do in Global Quality touches every part of our diverse organization. It’s reflected in our end-to-end Quality Management System that encompasses R&D, Manufacturing & Distribution, Commercial, Vaccines and our BioLife Plasma collection network. When you’re a part of our team, you’ll do meaningful work that makes an impact on the lives of patients. Learn more about us and explore the opportunities to build a remarkable career.
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Job Description
Über die Rolle:
Fachliche Koordination in der Etablierung, Betreuung, und Weiterentwicklung von computerized systems im GxP Umfeld im Bereich der Qualitätskontrolle der biopharmazeutischen Herstellung von Wirkstoffen.
Ihre Aufgaben:
Implementierung und Wartung von computerized systems in Übereinstimmung mit den Anforderungen 9CFR pt 11, EU GMP Annex 11 und OECD advisory document Nr. 17 (+ supplement)
Sicherstellung, dass alle Systeme den aktuellen GLP/GMP-Standards und Richtlinien für elektronische Aufzeichnungen / Signaturen und Datenintegrität entsprechen
Leitung der Validierung von computerized systems in Zusammenarbeit mit funktionsübergreifenden Teams
Erstellung von Benutzer-Anforderungsspezifikationen und SOPs
Bereitstellung von Schulungen und Unterstützung der Endanwender zu Systemfunktionen und Compliance-Anforderungen
Präsentation bei Audits, insbesondere bezüglich Wartungsaktivitäten, Datenintegrität und Datensicherheit der computerized systems
Effektive Kommunikation mit Stakeholdern zur zeitnahen Abstimmung
Kontinuierliches Monitoring von best practices der Branche und regulatorischer Änderungen im Zusammenhang mit comuputerized systems
Proaktive Entwicklung von Verbesserungsmöglichkeiten
Ausgeprägte Aufmerksamkeit für Details und Genauigkeit bei der Ausführung von Aufgaben
Aufrechterhaltung eines hohen Standards an Professionalität und Integrität in allen Interaktionen
Das bringen Sie mit:
Fachschul- oder HTL-Abschluss mit relevanter Berufserfahrung, FH- oder Univ. Abschluss Naturwissenschaften, Erfahrung in der Produktion im GxP Umfeld, idealerweise (Bio)Pharmazie
Kenntnisse der GxP Anforderungen für computerized systems
Hohes Verantwortungsbewusstsein, Zuverlässigkeit und Genauigkeit
Hohe Einsatzbereitschaft und Eigenständigkeit, ausgeprägtes Qualitätsbewusstsein, gute Kommunikationsfähigkeiten, analytisch und lösungsorientiert, soziale Kompetenz
Sehr gute Sprachkenntnisse: Deutsch, Englisch
IT: Office, ERP (z.B. JDE), EQM (z.B. LIMS, TrackWise, …)
What Takeda can offer you:
A competitive remuneration package with a minimum salary of € 4.157,14 gross per month (full-time, collective wage agreement for the chemical industry) - the actual salary depends on your professional experience and qualifications.
Family-friendly company environment; Support with parental leave, dad month, Bilingual company kindergarten
Work @ home depending on the position / department
Comprehensive training programs
In-house job rotation program
In-house Canteen with discounts or meal vouchers
Works council (events, festivals, shopping vouchers, etc.)
Employee Referral Program
Employee Recognition Program
Takeda Resource Groups
Medical checkups
Free vaccination program
Fitness Center
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Empowering our people to shine:
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law.
Locations
AUT - Wien - Benatzkygasse 2-6Worker Type
EmployeeWorker Sub-Type
RegularTime Type
Full timeWorking at Takeda
-
Inclusion
Here, you will feel welcomed, respected, and valued as a vital contributor to our global team. -
Collaboration
A strong, borderless team, we strive together towards our priorities and inspiring mission. -
Innovation
Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients. -
Top Workplace
Recognized for our culture and way of working, we’re one of only 17 companies to receive Top Global Employer® status for 2024. -
Work-Life
Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family. -
Empowerment
Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.
We're Steadfast In Our Commitment to Four Key Imperatives
Patient
Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.
People
Create an exceptional people experience.
Planet
Protect our planet.
Data & Digital
Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.
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