『保瑞-中壢廠』QA Associate

1. To maintain site Laboratory Investigation, Deviation and CAPA Management Systems and perform Track and Trend for deviation & CAPA status and to coordinate deviation investigations related to process during products manufacturing and packaging operations on-site or at CMOs/CPOs. 2. To coordinate Product Quality Complaint investigation/FAR actions and perform Complaint management which involve Track and Trend for complaints status and resolution. 3. To coordinate investigation committee meetings to facilitate discussion to identify impact, root cause(s) in order determine effective CAPAs implementation. 4. To coordinate Annual Product Review reporting activities for the site. 5. To provide support for handling inspection of agency (FDA, TFDA), or external audits from the sponsors/customers. 6. Support SOP revision, daily update of investigation status, quality metrics collection. 7. Other tasks as assigned by the company.