Gather and analyze information for product codes, device descriptions,FDA listing numbers and GMDN codes. Design, develop, test, document & support of cGxP systems as per 21 CFR Part11 & US FDA. Responsible for qualification & validation (IQ/OQ/PQ),master plans, protocols, changes requests, gap & root cause analysis, risk management plans, traceability matrix, summary reports for facilities, equipment, systems & processes.Prepare, review, authorize & submission of documentation for quality compliance & regulatory authorities.

Bachelor’s degree or higher in Science, Technology, or Engineering (any), Medicine, or Pharmacy, with a minimum two plus years of experience is required.