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
Job Duties: Understand 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 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 support manufacturing in the plant. Lead the planning for all validation testing activities (OQ, PQ and Pre- Validation UAT protocols). Develop validation strategy and plan execution of Operational and Performance Qualification protocols to meet the 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 including system flow diagram specifications, configurations, and design specifications. Participate in internal or external training programs to maintain knowledge of validation principles. Use test management tools for tracking validation activities, test results and test defects.
Job Requirements: Required Masters or foreign equivalent in CS, Biotechnology, CIS, MIS, Engineering (Any), or any related field. Must be able to travel/relocate to various client sites throughout the U.S.
Location of work: Santa Clara, CA .
Apply to Infotech Spectrum, Inc.,2060 Walsh Avenue,Suite 120, Santa Clara, CA 95050, to email@example.com