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Computerized Systems Owner

vor 2 Monaten


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 assurance team, you will be responsible for the implementation, maintenance, and validation of computerized systems in our GxP environment.

Key Responsibilities
  • Implement and maintain computerized systems in accordance with 9CFR pt 11, EU GMP Annex 11, and OECD advisory document Nr 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
  • Develop user requirement specifications and SOPs
  • Provide training and support to end-users on system functionality and compliance requirements
  • Present at audits, particularly regarding maintenance activities, data integrity, and data security of computerized systems
  • Effective communication 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
Requirements
  • Fachschul- or HTL degree with relevant work experience, or FH or Univ. degree in natural sciences, experience in production in GxP environment, preferably (Bio)Pharma
  • Knowledge of GxP requirements for computerized systems
  • High sense of responsibility, reliability, and accuracy
  • High level of commitment and self-motivation, developed quality awareness, good communication skills, analytical and solution-oriented, social competence
  • Very good 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 certified as a Global Top Employer and offer stimulating careers, encourage innovation, and strive 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.

What We Offer
  • 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