Senior Quality Engineer

**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) **Job Description** Main Responsibilities: * To perform the role of Sr. Quality Engineer, assist QA Management in maintaining quality management system. * Plan, conduct, and report audits including supplier, internal and other audit, and follow up on audit observations and CAPAs to ensure timely and effective closure. * Manage and improve the process of new and existing supplier assessments and keep the Approved Supplier List updated. * Assist and coordinate in regulatory and client audits. Follow up the implementation of audit response and actions for audit finding. * Manage and improve pre and post review and approval process of production batch records. * Management of Deviation/Complaint and CAPA system as per FCS procedure. Review and approve the problem report as the QA representative. * Manage and improve the process of QA release of finished products in GPMS. * Manage and improve site document control and training process. * Maintain and manage site archives. * 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. * 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 etc. * Management of validation/qualification systems. Review and approve validation protocol and report as the QA representative. * Coordinate Recall event and organize annual 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. Minimum Requirement: * Education: Bachelor's degree in life science, chemical or pharmaceutical/ medical related. * Years of Experience: More than 3 years of experience in Quality Assurance or Quality Control, including GxP auditing experience. Experience working in a GMP pharmaceutical manufacturing company is required. Preferred Experience and Skills: * Advanced understanding and grasp of quality management, GxP, preferably the knowledge of clinical trial materials. Knowledge in supply chain or warehouse operation will be plus. * Good communication skills. Good written and spoken English. Problem solving / Decision making. Detailed-oriented.