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Asst Mgr, IT

Req #: 170006HJ_en
Location: Bangalore, KA IN
Job Category: Information Technology
Date Posted: 8/11/2017 10:46:38 AM
Baxter International
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 mentoring offshore validation resources, monitoring compliance to the Baxter Global Procedures GQR/GQP, Baxter Quality Management System (QMS) Requirements, and other established Global IT policies/procedures.
  1. 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.
  2. Responsible for creating and/or approving the documents required for the development and validation of the computerized system.
    1. Prepares documentation within a validation package per policy and procedure to support the validation of enterprise systems and IT infrastructure.
    2. Approves the Validation Plan, Data Migration Plan,  Risk Management Report, User Requirements Specification,  Functional Specification, Configuration Specification, Design Specification, Design Review, Data migration Specification, qualification protocol, User Manuals, System Procedures, Validation/Qualification Reports,  Trace Matrix, System Description, and Validation Report.
    3. Coordinates and executes protocols – executes the overall protocol process, including test case creation/approval, test case execution reviews, test incident management, and status reporting
    4. Coaches third party testers on good testing and documentation practices.
  3. Supports Global IT Quality Compliance in creating or reviewing deliverables as necessary.
    1. Create end to end Validation life-cycle deliverables
    2. Approve Infrastructure and Application change  controls (pre and post)
    3. Coaches or completes problem reports related to IDC activities.
  4. Provide leadership to offshore validation resources.
    1. Guide, mentor and motivate team members to think more broadly related to cross-functional/business risk management.  Provide formal performance review feedback for team resources.
    2. Contributes to or gathers CSV/Quality/Risk metrics for reporting purposes
  5. Quality Awareness
    1. Responsible for understanding and communicating Baxter’s Quality Management System structure and process to offshore validation resources as well as IT teams.
    2. Responsible for review and approval of local procedures governed by Global IT Quality Compliance.
    3. Manages/Owns Corrective and Preventive (CAPA) reports related to IDC team members or contributes to Global IT CAPAs
    4. Coaches IDC team members on Baxter quality process (document management, good documentation practices,
  1. Minimum of 8 years of experience in a quality systems environment, or equivalent work experience.
  2. Hands on experience in reviewing as well as authoring end to end Validation SDLC Life-cycle documents.
  3. Experience in reviewing and approving Infrastructure and Application Change Controls.
  4. Thorough knowledge of FDA and Annex 11 regulations and GAMP 5 standards.
  5. Experience in Pharmaceutical and/or Medical Device Industry.
  6. Excellent analytical and judgment capabilities and communication skills, and the ability to work with both IT management and staff.                                    
  7. Solid oral and written communication skills and teamwork skills.
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