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IT Quality Specialist
hace 2 meses
About Us
Baxter is a global leader in healthcare, dedicated to saving and sustaining lives. Our mission is to improve outcomes for millions of patients worldwide.
We are transforming our global IT function to strengthen partnerships and enable more efficient and connected business processes. This requires agile and innovative thinking to reveal new ways of working.
Your Role
As a Sr. Spec, IT, you will provide management support to the ITQC Team and serve as a Computer System Integrity expert on the Global Systems from both a business and technical perspective.
Your responsibilities will include:
- Documentation Management using document management tools.
- Using Test Management tools such as Micro Focus ALM.
- Ensuring Agile Scrum Principles.
- Managing CHG CTRL management in IT Now/TW8.
- Qualifying SW at the global level and landing zones at AWS & Azure.
- Collaborating with a diverse and inclusive group of collaborators.
Requirements
To succeed in this role, you will need:
- A Bachelor's degree in computer technology, engineering, mathematics, chemistry/biology, information management, or a related field.
- 5+ years of experience in IT Quality and Compliance, especially ERP system validation, upgrade, and roll-outs, and Data integrity-oriented assessment of Computerized Systems.
- Writing and execution of CSV work (VP, URS, RA, IQ/OQPQ, TMX, VR).
- Implementation of Risk-based methodologies in the GxP Validation lifecycle and Organizational Change for ERP systems (JDE, GME, WMS, WCS), as well as coordinating risk management of new or changed computerized Systems.
- Responsible for ERP rollouts and implementation using a scalable lifecycle approach.
- GMP, 21 CFR Part 11, Eudralex Annex 11, ISPE GAMP 5, Data integrity mentorship (WHO, MHRA, FDA...), Prince 2 (Foundation Level).
Why Baxter?
Baxter offers a dynamic and inclusive work environment where you can make a positive impact on people's lives. We are committed to innovation, collaboration, and excellence in all that we do.
