Baxter require Validation Specialist

Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-centre dialysis;sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy, automation, software and services. Baxter GDC a global IT shared services center, in Bangalore to deliver Baxter’s global enterprise IT needs. We develop and deploy enterprise wide IT solutions that support critical operations from HR to Manufacturing, Finance, Quality Compliance, Legal and other functions within the organization.

Post : Validation Specialist

Job Description
This position will be focused on ERP upgrade assignment
• 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

Candidate Profile

• 3 to 5 years of experience in a quality systems environment, or equivalent work experience.
• 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.
• Excellent analytical and judgment capabilities and communication skills, and the ability to work with both IT management and staff.
• Solid oral and written communication skills and teamwork skills

Additional Information
Experience : 3 to 5 years
Qualification : M.Pharm, M.Sc
Location : Bangalore
Industry Type : Pharma
Functional Area : Information Technology
End Date : 21st August, 2018