Work Schedule

Environmental Conditions

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.