Aktuelle Jobs im Zusammenhang mit GxP Systems Specialist - Wien, Wien - Takeda Pharmaceutical
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IT Infrastructure Systems Specialist
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Embedded Systems Integration Specialist
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GxP Systems Specialist
vor 2 Monaten
We are seeking a highly skilled and experienced professional to join our team as a Computerized Systems Manager. In this role, you will be responsible for the coordination, maintenance, and development of computerized systems in the GxP environment within the Quality Control department of our biopharmaceutical manufacturing facility.
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 industry best practices and regulatory changes related to computerized systems.
- Proactively develop improvement opportunities.
- Demonstrate a high level of attention to detail and accuracy in the execution of tasks.
- Maintain a high standard of professionalism and integrity in all interactions.
- A degree in a relevant field, such as natural sciences, with relevant work experience, or a degree in a related field with experience in the GxP environment.
- Knowledge of GxP requirements for computerized systems.
- A high sense of responsibility, reliability, and accuracy.
- A high level of initiative 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,...).
Takeda is a global pharmaceutical company that is 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 our employees 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.
Our Commitment to 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.
