Computerized Systems Specialist

vor 1 Monat

Wien, Wien, Österreich Takeda Vollzeit

Job Summary

As a Computerized Systems Owner at Takeda, you will be responsible for the establishment, maintenance, and development of computerized systems in a GxP environment.

Key Responsibilities

  • Implement and maintain computerized systems in accordance with 9CFR pt 11, EU GMP Annex 11, and OECD advisory document Nr. 17 (+ supplement)
  • 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
  • Create user requirement specifications and SOPs
  • Provide training and support for end-users on system functionality and compliance requirements
  • Present at audits, particularly regarding maintenance activities, data integrity, and system security
  • Effective communication with stakeholders for timely coordination
  • Continuously monitor industry best practices and regulatory changes related to computerized systems
  • Proactive development of improvement opportunities
  • High attention to detail and accuracy in task execution
  • Maintenance of a high standard of professionalism and integrity in all interactions

Requirements

  • Degree in a relevant field or equivalent experience, ideally in (Bio)Pharmaceuticals
  • Knowledge of GxP requirements for computerized systems
  • High sense of responsibility, reliability, and accuracy
  • High level of initiative and independence, excellent 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 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.

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.

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