Sr. 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.