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 and systems that supports manufacturing in the plant.Lead the planning for all validation testing activities(IQ),(OQ)and(PQ) protocols and Pre-validation UAT protocols.Develop Test Strategies and Plan in execution of (IQ),(OQ)and(PQ)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(RTM)and Prepare Test Summary Reports to summarize all the test activities including any open deviations.Manage authoring of Risk Assessments. Track and monitor review and approval of validation deliverables participate in meetings with project team and Client Stakeholders.Develop User Requirements, System Requirements including system flow diagram Specifications, Configuration and Design Specifications.Participate in internal and external training programs to maintain knowledge of validation principles. Use Test Management tools for tracking validation activities, test results and test defects. Use change control management system to release and update controlled documents, route engineering change orders and maintain the standard operating procedure documents.
Job Requirements: Required Masters or foreign equivalent in CS, Information Systems Technologies-Information Assurance, CIS, MIS, Engineering (Any), or any related field. Must be able to travel/relocate to various client sites throughout the U.S.