Senior IT Specialist

hace 6 días

Guadalajara, Jalisco, México Baxter A tiempo completo

Where Innovation Meets Care

At Baxter, our mission connects us all. Regardless of your position, your contributions positively influence lives globally. You'll experience a profound sense of purpose, knowing that your efforts enhance the well-being of countless patients.

With a legacy of over 85 years, Baxter's groundbreaking medical products and therapies are utilized in hospitals, clinics, and homes worldwide. We are committed to pioneering advancements that redefine healthcare.

Together, we cultivate an environment where success and inspiration thrive. This is where you can excel in your career.

About Our Transformation

At Baxter, we believe that progress is essential. Our global IT function is undergoing a transformation aimed at fostering stronger partnerships and streamlining business processes. In the ever-evolving healthcare landscape, we must remain agile and innovative to tackle emerging challenges. Our technological advancements and digital capabilities will create a more efficient ecosystem, empowering our employees, customers, and products to achieve superior patient outcomes.

Your Responsibilities

The Senior IT Specialist plays a pivotal role in providing management support to the IT Quality Control Team and serving as a Computer System Integrity expert across Global Systems from both business and technical perspectives.

This position leads validation efforts for all applications deployed on AWS or Azure, focusing on critical areas that influence computer system integrity. The role encompasses the following responsibilities:

  • Managing documentation through a document management system.
  • Utilizing the Test Management tool, Micro Focus ALM.
  • Ensuring adherence to Agile Scrum methodologies.
  • Overseeing Change Control management in IT Now/TW8.
  • Validating software at a global level and within AWS & Azure landing zones.
  • Collaborating with a diverse and inclusive team of professionals.

Qualifications

  • A Bachelor's degree in computer technology, engineering, mathematics, chemistry/biology, information management, or a related field is required.
  • A minimum of 5 years of experience in IT Quality and Compliance, particularly in ERP system validation, upgrades, rollouts, and data integrity assessments of computerized systems.
  • Proficiency in writing and executing all CSV documentation (VP, URS, RA, IQ/OQPQ, TMX, VR).
  • Experience implementing risk-based methodologies in the GxP validation lifecycle and managing organizational change for ERP systems (JDE, GME, WMS, WCS), including coordinating risk management for new or modified computerized systems.
  • Responsibility for ERP rollouts and implementations using a scalable lifecycle approach.
  • Knowledge of GMP, 21 CFR Part 11, Eudralex Annex 11, ISPE GAMP 5, and data integrity mentorship (WHO, MHRA, FDA...), as well as Prince 2 (Foundation Level).

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