Validation Analyst

ITVorks Inc., seeks ValidationAnalysts for its Princeton, NJ office to Review documents including clinicalstudy reports, labeling drafts and validation and stability protocols andreports. Develop and Execute Installation, Operational, and PerformanceQualification (IQ, OQ and PQ) protocols, and prepare Test Plan and FinalValidation Report. Perform GAP analysis on GXP system that directly affectsproduct quality and Data Integrity and ensure all the requirements have beentested and also comply with applicable FDA Regulations. Prepare validation orperformance qualification protocols for new or modified manufacturingprocesses, systems, or equipment for pharmaceutical production. Prepare andsubmit of Chemistry, Manufacturing, and Controls (CMC) sections for regulatorydrugs and submissions, information amendments, supplements, and annual reports.Travel to various unanticipated locations in the United States to interact withclients for short or long term assignments. Master's Degree or foreignequivalent in Pharmacy/Regulatory Affairs/Chemistry or related + 1 yr ofexperience as Clinical Analyst, Regulatory Affairs Associate, QA Engineer orrelated, developing/creating Test Plan, and using software validation lifecycle and EDC applications (Medrio, RAVE and Inform) is required. Work Location: Princeton, NJ. Travel required to interact with clients & train end users. Pleasesend resume & cover letter indicating position and Job Code to . Human Resources, ITVorks Inc., 101College Rd East, Suite #302, Princeton, NJ 08540. #J-18808-Ljbffr

Created: 2024-11-12