Computer Systems Specialist

vor 1 Woche

Wien, Wien, Österreich Takeda Vollzeit
Job Description

As a Computerized Systems Owner at Takeda, you will play a crucial role in the establishment, maintenance, and development of computerized systems in the GxP environment within the quality control department of biopharmaceutical production of active substances.

Your Responsibilities:
  • Implement and maintain computerized systems in accordance with the requirements of 9 CFR pt 11, EU GMP Annex 11, and OECD advisory document No. 17 (supplement).
  • Ensure that all systems meet the 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 functions and compliance requirements.
  • Present at audits, particularly regarding maintenance activities, data integrity, and data security of computerized systems.
  • Effectively communicate with stakeholders to ensure timely coordination.
  • Continuously monitor best practices in the industry and regulatory changes related to computerized systems.
  • Proactively develop improvement opportunities.
  • Maintain a high standard of professionalism and integrity in all interactions.
What You Bring:
  • A degree in a relevant field (e.g., natural sciences, engineering) or equivalent experience in the production environment.
  • Knowledge of GxP requirements for computerized systems.
  • High sense of responsibility, reliability, and accuracy.
  • High level of commitment and self-motivation, with a strong focus on quality, good communication skills, analytical and solution-oriented, and social competence.
  • Excellent language skills: German and English.
  • IT skills: Office, ERP (e.g., JDE), EQM (e.g., LIMS, Track Wise).
What Takeda Offers:
  • 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.
  • A family-friendly company environment.
  • Support with parental leave, dad month, bilingual company kindergarten (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.

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