Aktuelle Jobs im Zusammenhang mit Computerized Systems Specialist - Wien, Wien - Takeda Pharmaceutical
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Associate Quality Assurance Specialist
vor 1 Woche
Wien, Wien, Österreich AOP Orphan VollzeitAOP Health is the European pioneer for integrated therapies for rare diseases and critical care. We are looking for a talented professional to join our team in Vienna. The Associate Quality Systems position plays a key role in ensuring superior quality systems. You will manage critical processes, help keep processes running smoothly, and shape our commitment...
Computerized Systems Specialist
vor 2 Monaten
We are seeking a highly skilled and experienced professional to join our team as a Computerized Systems Owner. As a key member of our quality assurance team, you will be responsible for ensuring the integrity and compliance of our computerized systems in the GxP environment.
Key Responsibilities- Implement and maintain computerized systems in accordance with 9 CFR 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 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
- Relevant education and experience in a GxP environment, preferably in the pharmaceutical industry
- Knowledge of GxP requirements for computerized systems
- High sense of responsibility, reliability, and accuracy
- High level of initiative and self-motivation, with a strong focus on quality and compliance
- Excellent communication and analytical skills, with the ability to work independently and as part of a team
- Proficiency in Microsoft Office and ERP systems (e.g., JDE), as well as EQM systems (e.g., LIMS, Track Wise)
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 and inclusive workplace, where our employees can grow and thrive. As a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do.
We are proud to be an equal opportunities employer and welcome applications from all qualified candidates. If you are passionate about quality, compliance, and innovation, and are looking for a challenging and rewarding role, please submit your application.
