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Quality Control Systems Owner

vor 2 Monaten

Wien, Wien, Österreich Takeda Pharmaceutical Vollzeit

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.

Job Overview:

In this role, you will be responsible for the technical coordination in the establishment, maintenance, and enhancement of computerized systems within the GxP environment, specifically in the quality control sector of biopharmaceutical manufacturing.

Your Responsibilities:
  • Implementation and maintenance of computerized systems in compliance with 9CFR pt 11, EU GMP Annex 11, and OECD advisory documents.
  • Ensuring that all systems adhere to current GLP/GMP standards and guidelines for electronic records/signatures and data integrity.
  • Leading the validation of computerized systems in collaboration with cross-functional teams.
  • Developing user requirement specifications and standard operating procedures (SOPs).
  • Providing training and support to end-users regarding system functionalities and compliance requirements.
  • Presenting during audits, particularly concerning maintenance activities, data integrity, and security of computerized systems.
  • Effectively communicating with stakeholders for timely alignment.
  • Continuously monitoring industry best practices and regulatory changes related to computerized systems.
  • Proactively identifying and developing improvement opportunities.
  • Demonstrating a strong attention to detail and accuracy in task execution.
  • Maintaining a high standard of professionalism and integrity in all interactions.
Your Qualifications:
  • Technical school or HTL degree with relevant professional experience, or a bachelor's degree in natural sciences, with experience in GxP production, preferably in (bio)pharmaceuticals.
  • Knowledge of GxP requirements for computerized systems.
  • High sense of responsibility, reliability, and precision.
  • Strong commitment and independence, with a pronounced quality awareness, good communication skills, and analytical problem-solving abilities.
  • Proficient language skills in German and English.
  • IT proficiency: 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.

  • Family-friendly company environment; support with parental leave, dad month, bilingual company kindergarten.
  • Flexible work-from-home options 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. Takeda is a patient-focused company that will inspire and empower 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.

Diversity and Inclusion:

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.