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Specialist - Testing

Req # JR - 062840 Location Bengaluru, Karnataka, India Job Category Information Technology Date posted 03/15/2022

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.

This position is accountable for contributions to the quality of multiple project delivery by performing project-applicable Quality Compliance functions in a global environment, and ensuring that the Computer systems meet the defined requirements.  The individual is responsible for compliance to the Baxter Global Procedures GQR/GQP, Baxter Quality Management System (QMS) Requirements, and other established Global IT policies/procedures.

Responsible for assuring a system/application meets its requirements and is compliant with applicable Baxter QMS documents, and the documentation set outlined in the Validation Plan for the project. Responsible for creating  the documents required for the development and validation of the computerized system.

Prepares documentation within a validation package per policy and procedure to support the validation of enterprise systems and IT infrastructure.

Creates the Validation Plan, Qualification Protocol, Qualification report(s) Final validation report, Trace Matrix, System Description,  Data Migration Plan,  Qualification protocol, User Manuals, System Procedures, Validation/Qualification Reports,  Trace Matrix, System Description, and Validation Report.

Coordinates the preparation and routes the following validation documents:  Risk Management Report, User Requirements Specification, Functional Specification, Configuration Specification, Design Specification, and Data Migration Specification.

Completes final document processing to release validation documents within the document management system.

Coordinates and executes protocols – executes the overall protocol process, including test case creation/approval, test case execution reviews, test incident management, and status reporting

Coaches third party testers on good testing and documentation practices.

Supports Global IT Quality Compliance in creating or reviewing deliverables as necessary.

Create end to end Validation life-cycle deliverables

Approve Infrastructure and Application change  controls (pre and post)

Coaches or completes problem reports related to IDC activities.

Desired skills / certifications / training

Hands on experience in reviewing as well as authoring end to end Validation SDLC Life-cycle documents. Experience in reviewing and approving Infrastructure and Application Change Controls. Thorough knowledge of FDA and Annex 11 regulations and GAMP 5 standards. Experience in Pharmaceutical and/or Medical Device Industry.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to [email protected] and let us know the nature of your request along with your contact information.

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