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. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.
Post : Validation Specialist
Job Description
- 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
• 6+ 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:
Location: Bangalore
Education: Bachelor’s Degree
Experience : 6+ years
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Information Technology
End Date: 10th May, 2018
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