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Validation Analyst
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- 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.
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