【正文】
篇三 Take the local process owner of Track Wise system, and responsible for system users initial training. Management of Deviation and CAPA system as per FCS procedure. Review and approve the problem report as the QA representative. Monitor product plaint handling, and if necessary product recall. Manage and monitor GxP related change to ensure that can identify the potential risk and take the mitigation action. Management of selfinspection programme. Arrange the implementation of selfinspection and follow up the pletion of actions timely. Assist QA Manager in regulatory and client audits. Follow up the implementation of actions for audit finding. Perform pre and post review and approval of production batch records. Responsible for QA release of labelled products in GPMS. Perf