: As a Validation Engineer you will be providing technical services.
* Understanding the drug development process, medical devices development and FDA regulations * Develop Validation Plan to define the validation strategy to be compliant with FDA regulations and client company policies * Apply Process Validation, Regulatory requirements and Drug development process knowledge and experience to analyze the requirements * Perform the IT Validation activities for FDA regulated applications/ Systems across multiple computing environments * Understand the Client Validation Procedures and Requirements in validating new or modified processes, systems that supports manufacturing in the plant * Lead the planning for all validation testing activities (OQ, PQ and Pre-validation UAT Protocols). * Develop Test Strategy and Plan in execution of Operational and Performance protocols to meet company policies and procedures * Execute validation test protocols and document the test results * Develop defect reports, and track them for its resolution and maintain Requirements Traceability Matrix (RTM) and Prepare Test Summary Report to summarize all the test activities including any open deviations * Track and Monitor review and approval of validation deliverables, participate in meetings with project team and Client Stakeholders as required * Develop User Requirements, System Requirements including system flow diagram Specifications, Configuration and Design Specifications * Participate in Internal or external training programs to maintain k knowledge of validation principles * Use HP Quality Center for tracking validation activities, test results and test defects
Requirements: . The position requires at least a Bachelor's degree or Computer Science, Biotech, Health Informatics, Instrumentation, Computer Information Systems, Electrical Engineering, Electronics, or related degree Apply to this Position!
InfoTech Spectrum Inc
Infotech Spectrum Inc. All Rights Reserved.
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