Involve in the design, development, implementation, testing, documentation & support of cGxP systems as per 21CFR 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. Preparation, review, authorize & submission of documentation for quality compliance & regulatory authorities. Master's degree in Science, Pharmacy, Biotechnology, Chemistry, Biochemistry, Chemical Engineering, Mechanical Engineering, Industrial Engineering, Biomedical Engineering, Regulatory Affairs, or related field along with 6 months of experience in job offered or related occupation is required. Work location: South Plainfield, NJ and various unanticipated locations throughout the U.S.Send Resume to HR Dept., Katalyst Healthcares & Life Sciences, Inc., 285 Durham Avenue, Suite 12, South Plainfield, NJ 07080.
