Validation Analysts: Review documents including clinical study reports, labeling drafts and validation and stability protocols and reports. Develop and Execute Installation, Operational, and Performance Qualification (IQ, OQ and PQ) protocols, and prepare a Final Validation Report. Perform GAP analysis on GXP system that directly affects product quality and Data Integrity and ensure all the requirements have been tested and also comply with applicable FDA Regulations. Prepare validation or performance qualification protocols for new or modified manufacturing processes, systems, or equipment for pharmaceutical production. Prepare and submit of Chemistry, Manufacturing, and Controls (CMC) sections for regulatory drugs and submissions, information amendments, supplements, and annual reports. Travel to various unanticipated locations in the United States to interact with clients and train end users for short or long term assignments
Work Schedule: 8:30 am-5:30pm; 40 Hrs/week (M-F)
Requirements: BS or foreign equivalent in Pharmacy/Chemistry/Regulatory Affairs or related + 2 yrs as Clinical Data Analyst, Regulatory Affairs Associate, QA Analyst or related, processing PMA Submission and using clinical data management systems, software validation life cycle, Test Plan, EDC applications (Medrio, Inform, RAVE), or SAS Programming.
Job Location: 101 College Road East, Suite 301, Princeton, NJ 08540
Contact: Moushmi Saha, HR Manager
Aplomb Technologies, Inc.
101 College Road East, Suite 301
Princeton, NJ 08540