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Computerized Systems Owner
vor 2 Monaten
About the Role:
This is a challenging opportunity for a skilled professional to join our team at Takeda as a Computerized Systems Owner - GxP Expert. As a key member of our quality control team, you will be responsible for the establishment, maintenance, and development of computerized systems in the GxP environment.
Your Key Responsibilities:
- Implement and maintain computerized systems in accordance with 9CFR pt 11, EU GMP Annex 11, and OECD advisory document requirements.
- 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 functionality 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'll Bring:
- A bachelor's degree or higher in a relevant field, with relevant work experience, or a degree in natural sciences with experience in production in the GxP environment.
- Knowledge of GxP requirements for computerized systems.
- A high sense of responsibility, reliability, and accuracy.
- A 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, TrackWise,...).
About Takeda:
Takeda is a patient-focused company that is transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. We are committed 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 any other characteristic protected by law.
