Computer Systems Specialist

vor 3 Wochen

Wien, Wien, Österreich Takeda Vollzeit

Job Description:

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 accordance with GxP regulations.

Your Key Responsibilities:

  • Implement and maintain computerized systems in compliance 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
  • 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 system security
  • Effective communication with stakeholders to ensure timely coordination
  • Continuously monitor best practices in the industry and regulatory changes related to computerized systems
  • Proactively identify opportunities for improvement
  • Maintain a high standard of professionalism and integrity in all interactions

What You Bring:

  • Relevant education and experience in a GxP environment, preferably in the pharmaceutical industry
  • Knowledge of GxP regulations for computerized systems
  • High sense of responsibility, reliability, and accuracy
  • High level of self-motivation and independence, 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, TrackWise,...)

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.

  • 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

About Us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. We are a patient-focused company that inspires and empowers 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 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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