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Baxter
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Analyst IT

Analyst IT

Baxter

3 - 6 years

14 - 16 Lacs

bengaluru

Posted:4 hours ago| Platform:

Apply

Skills Required

it analyst design review test management tool quality systems healthcare test planning document management risk management mhra recruitment

Work Mode

Work from Office

Job Type

Full Time

Job Description

This position is accountable for performing activities in support of the validation and compliance of a computerized system to ensure the system meets its intended use. This position will work with IT team(s) to ensure a computerized system is compliant with applicable regulations (21 CFR Part 11, GxP Regulations) and Baxter Quality Management System requirements.

Support the Validation activities during the deployment of any new GxP Application.

What you ll be doing

Review project teams work to ensure quality (design walk-through, code review, test results, etc.) and alignment to the processes, standards, and regulatory requirements.
Responsible for the conduct of Verification and Validation activities as per requirements defined in Baxter Design Control Method and regulatory requirements.
Responsible for assuring the new Computerized System meets the requirements of the systems users & Regulatory requirements.
Creating, managing, and /or maintaining the documents required by Baxter quality systems procedures for the development and validation of the Computerized System.
Responsible for oversight of protocol execution.
Shall control the Validation Package and shall ensure that all documents contained in the Validation Package are maintained per document retention policies/procedures.
Coordinate risk management of new or changed computerized Systems.
Ensure design review and application acceptance including completeness of Trace Matrix (link among user requirements, functional requirements, design requirements and test plan)
Communicate and control the adherence to validation standards by the team.
Provide support to the functional team/users for the development of validation deliverables (functional specification, technical specification, system & user procedures, etc).
Support the processes to maintain in a controlled state of validation during the entire life cycle of Computerized Systems.

What you ll bring

Bachelor s degree in science, engineering, or technology and meaningful work experience required.
3+ years of Quality or IT system development experience is required.
Good knowledge of GxP regulations (e.g. 21 CFR Part 11, GAMP 5, MHRA etc.), Standards, and Industry Best Practices.
Good communication skills.
Strong knowledge of software development/implementation processes.
Knowledge and experience in the following areas:

Documentation Management using document management tool.
Test Management tool Micro Focus ALM

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Analyst IT