Responsibilities:
Work in different stages of validation such as design, development, installation, operational, and performance of Computer Systems, Software, Lab equipment and Medical Devices.
Adhere to quality, regulatory and GxP standards.
Review and update IQ/OQ/PQ Summary and Validation Final Reports.
Review the SIT/UAT test cases and conduct pre and post approvals.
Understand GAMP 5, 21 CFR part 11, and Computer System Validation.
Perform CAPA process, closed deviations. Perform GAP analysis and Root Cause Analysis.
Manage user change requests and change process. Author and update SOP’s.
Prepare, review, authorize & submit documentation for quality compliance to regulatory authorities.
Master’s degree in Science, Technology, Engineering, or any related field is required.
Bachelor’s degree in the above fields along with 5 years of experience in job offered or related occupation is acceptable in lieu of Master’s degree.
Any suitable combination of education, training or experience is acceptable.
Work location: Piscataway,NJ and various unanticipated locations throughout the U.S.