Work as Validation Specialist at Baxter
Post : Validation Specialist
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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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