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.

Bachelor degree, prefer major in Biotech, Chemical and pharma related field.

5+ working experience as a QA in healthcare industry

Experienced in managing Deviation/Complaint

Good verbal and written English