Quality Assurance Executive

1 week ago

Singapore Leung Kai Fook Medical Co Pte Ltd Full time

Job Descriptions Maintain and continuously improve the QMS. Serve as the document controller for the Quality Manual, Standard Operating Procedures, Specifications, Work Instructions, Forms, Charts, Records and Quality Reports. Ensure compliance with GMP, PIC/s, ICH, ASEAN Guidelines, FDA, and other regulatory requirements. Prepare the annual Product Quality Review Report and Management Review Reports. Manage and follow up on change controls. Conduct process deviation investigations and follow up on CAPA implementation for closure. Handle quality issues in manufacturing operations. Manage customer complaints, product recalls, returns, and counterfeits cases. Review and control artwork and drawings for packaging materials. Ensure machine testing, trial runs, qualifications, and validation meet compliance requirements. Monitor accelerated and real‐time stability programs. Ensure that Good Documentation Practices and traceability are in place. Undertake any additional tasks as assigned from time to time. Job Requirements Degree in Pharmaceutical Science, Engineering, or a related field. At least 2 years of experience in quality assurance within the pharmaceuticals, manufacturing, or medical devices industries Strong knowledge of QMS (e.g. ISO 9001, cGMP) with hands‐on experience in documentation control and implementation. Proven expertise in QA processes, including investigations, change control, CAPA management, audits, and process validation. Excellent follow‐up, communication, and interpersonal skills Meticulous and well‐organised, and detail‐oriented. Proficient in Microsoft Office applications. Location: Macpherson Road Working Hours: 5 days week (8.00am – 5.15pm)#J-18808-Ljbffr

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