Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Manage and improve pre and post review and approval process of production batch records.Manage and improve the process of QA release of finished products in GPMS.Management of Deviation/Complaint and CAPA system as per FCS procedure. Review and approve the problem report as the QA representative.Take the administrator of TrackWise system, and responsible for system users management and initial training.Manage and improve site document control process, and responsible for Documentum system users management and initial training.Management of self-inspection programme. Arrange and coordinate the implementation of self-inspection and follow up the completion of actions timely. Perform self-inspection as qualified internal auditor and routine data integrity compliance check.Manage and monitor GxP related change to ensure that can identify the potential risk and take the mitigation action.Manage and improve the process of new and existing suppliers assessments and keep the Approved Supplier List updated.Maintain cold chain management, including shipper qualification report review, approved shipper box list update.Monitor facility environment condition, including calibration/maintenance/Pest Control activities verification and Business continuity planning program management and etc..Management of validation/qualification system. Review and approve validation protocol and report as the QA representative.Assist QA Manager in regulatory and client audits. Follow up the implementation of audit response and actions for audit finding.Coordinate Recall event and organize annul mock recall activity, prepare all required documents and records.Perform and support Incoming Inspection / Approval on Receiving and Returns.Perform and support packaging inspection and checks (including Computerized Label Inspection if applicable).

Perform ad-hoc duties as requested by line management.