Computerized Systems Owner

Vor 5 Tagen


Wien, Wien, Österreich Takeda Vollzeit

About the Role:

We are seeking a highly skilled Computerized Systems Owner to join our team at Takeda. As a key member of our quality control team, you will be responsible for the coordination, maintenance, and development of computerized systems in the GxP environment.

Your Responsibilities:

  • Implement and maintain computerized systems in accordance with 9CFR pt 11, EU GMP Annex 11, and OECD advisory document requirements.
  • Ensure all systems meet current GLP/GMP standards and guidelines for electronic records/signatures and data integrity.
  • Lead the validation of computerized systems in collaboration with cross-functional teams.
  • Develop user requirement specifications and SOPs.
  • Provide training and support to end-users on system functionality and compliance requirements.
  • Present at audits, focusing on maintenance activities, data integrity, and system security.
  • Effectively communicate with stakeholders to ensure timely coordination.
  • Continuously monitor industry best practices and regulatory changes related to computerized systems.
  • Proactively identify opportunities for improvement.
  • Maintain a high level of attention to detail and accuracy in task execution.
  • Upkeep a high standard of professionalism and integrity in all interactions.

What You'll Bring:

  • FH or Univ. degree in a relevant field, with relevant work experience, or a Fachschul/HTL degree with relevant experience.
  • Knowledge of GxP requirements for computerized systems.
  • High sense of responsibility, reliability, and accuracy.
  • High level of initiative, independence, quality awareness, good communication skills, analytical and solution-oriented, social competence.
  • Excellent language skills: German, English.
  • IT: Office, ERP (e.g. JDE), EQM (e.g. LIMS, TrackWise,...).

About Takeda:

Takeda is a patient-focused company that inspires and empowers you to grow through life-changing work. We are transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do.

Empowering Our People to Shine:

Takeda is proud of 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.



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    By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Position...


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