高级质量技术员的岗位职责 篇15

　　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 complaint 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 self-inspection programme. Arrange the implementation of self-inspection and follow up the completion 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.

　　Perform QC inspection of incoming goods according to FCS procedure and client specific requirement.

　　Responsible for the release of incoming purchased or client materials and approves material specifications.

　　To check the accuracy of returned goods and supporting documentation.

　　Assist to perform the assessments for new and existing suppliers, and keep the Approved Supplier List updated.

　　Perform ad-hoc duties as requested by line management.