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Computerized Systems Owner (f/m/d)

Vienna, Vienna
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At 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.

Job ID R0130490 Date posted 08/27/2024 Location Vienna, Vienna

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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 2-6

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
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Working 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.

What we believe in

Our values of Takeda-ism are Integrity, Fairness, Honesty and Perseverance, with Integrity as the core. These are brought to life through actions based on Patient, Trust, Reputation and Business, in that order.

Our belief in putting people first extends beyond our patients — it includes their families and communities, as well as our Takeda colleagues and their families.

We are committed to embracing our differences, valuing different perspectives, and fostering a culture of respect, inclusiveness and empowerment.

Our embedded Diversity, Equity & Inclusion (DE&I) strategy enables us to attract and retain exceptional talent, drives innovation, and helps address systemic inequalities in our communities.

  • Integrity

  • Fairness

  • Honesty

  • Perseverance

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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