專案確效工程師(Project & Validation Engineer)_竹南科學園區

•Support the project and validation manager in preparing Project Execution Plan and update site Validation Master Plan. •Prepare and implement qualification protocols (IQ, OQ, PQ) used in the production of pharmaceutical products. Where possible, as assigned by the project manager to manage projects related to movement and modification of the manufacturing equipment. •Implement qualification activities, validation protocols, and calibrations in accordance with the needs of the production schedules. •Conduct periodic review of URS/FRS/DDS or DQ to meet the latest regulatory requirements or guidelines from ICH or FDA CFR’s. •Assist in the development and revision of Validation SOPs. •Assist in troubleshooting of equipment and process deviations. •Provide timely and accurate information of validation parameters established for equipment and facilities. •Acts as liaison with Engineering, Technical Service, and Quality Assurance. •Assist engineers/technicians in the development and completion of validation studies and protocols as needed. •Other tasks as assigned by the company.