Infotech Spectrum delivers comprehensive fully integrated creative IT solutions ranging from IT consulting services to advanced technology deployment and product development. We are a global service company that specializes in providing dynamic software solutions to a diverse array of business concerns worldwide. Since our inception, we have mastered the unlimited potential of information technology to ensure our global partners have the ability to manage their time and business more efficiently
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