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Business Unit introduction:
The newly formed IBM Watson Health business unit is now looking for talented individuals destined to usher in the next era of healthcare. We live in a moment of remarkable change and opportunity. The convergence of data and technology is transforming healthcare and life sciences organizations in every way. New roles are being created that never existed before to meet the demands of this transformation.
We have an exciting opportunity for Validation Engineers- Design Controls Like FDA, MDD, HIPAA, GxP.
As a Validation Engineer specializing in Healthcare regulations and controls you will support the Watson Health solution teams with developing and delivering compliant platforms and solutions.
What youll do:
As a Watson Health Validation Engineer you will:
Create and revise Design Verification and Validation Procedures
Computer Software Validation Test execution along with Automation testing.
Participate in Design Verification and Validation Procedure Reviews
Setup and configure Test Equipment.
Perform dry runs and formal Verification and Validation activities as required
Perform remediation of V&V results as required
Record and close defects found during V&V activities; Investigate failures and retest as needed.
Computer Software Validation Test execution IQ, OQ, PQ
Perform Dry run Data Set Up test script execution for CAPA and Investigations, per Business, Functional Requirements and User Requirements and identify deviations system, design, workflow and documentations that complies with cGMP, GxP-FDA compliance regulated computerized system
Perform execution of approved test scripts to validate Test Results conforms with Design, FRS, URS, SOPs, Traceability Matrix in compliance with cGMP and GDP requirements.
Prepare, review, execute and summarize validation protocols
Serve as a technical resource for assessing validation requirements, solving test related problems, and developing strategies for problem prevention
Provide validation support for the review to ensure designs comply with current validation standards and are able to be adequately validated and maintained within validated control
How well help you grow:
Youll have access to all the technical and management training courses you need to become the expert you want to be
Youll learn directly from expert developers in the field; our team leads love to mentor
You have the opportunity to work in many different areas to figure out what really excites you
PG - MBA/PGDM
Job Location: Bangalore.
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