Sr Spec, IT

hace 4 meses

Guadalajara, México Baxter A tiempo completo

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

About Us

Nothing changes if nothing changes, which is why Baxter is transforming our global IT function—into one that will strengthen partnerships and enable more efficient and connected business processes In the dynamic healthcare industry, we need to be ready to face new challenges and opportunities. As we learn, we must be agile and innovative to reveal new ways of working. Technology and our digital capability will help create a more efficient and innovative ecosystem to enable our employees, customers and products to drive better outcomes for patients worldwide.

Your Role

Sr, Spec is a critical position to provide management support to ITQC Team as well as Computer System Integrity expert on the Global Systems from both a business and technical perspective.

The Sr, Spec leads validation activities for all applications deployed at AWS or Azure covering key areas that impact the computer system integrity. Currently, this role is serves in the following capacities to ensure the security posture of Baxter

What you'll be doing

Documentation Management using document management tool. Use Test Management tool Micro Focus ALM Ensure Agile Scrum Principles Manage CHG CTRL management in IT Now/TW8 Qualify SW at the global level and landing zones at AWS & Azure Collaborate with a diverse and inclusive group of collaborators

What you'll bring

Bachelor’s degree in computer technology, engineering, mathematics, chemistry/biology, information management or related field required. 5 years + 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 all the CSV work (VP, URS, RA, IQ/OQPQ, TMX, VR) Implementation of Risk based methodologies in GxP Validation lifecycle and Organizational Change for ERP system (JDE, GME, WMS, WCS), as well as, Co-ordinate risk management of new or changed computerized Systems. Responsible for ERP rollouts and implementation using scalable lifecycle approach. GMP, 21 CFR Part 11, Eudralex Annex 11, ISPE GAMP 5, Data integrity mentorship (WHO, MHRA, FDA…), Prince 2 (Foundation Level)

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