Quality Assurance Executive

2 weeks ago

Macpherson, Singapore Leung Kai Fook Medical Co Pte Ltd Full time $60,000 - $120,000 per year

Job Descriptions:

  • Maintain and continuously improve the Quality Management System (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)

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