Quality Assurance Executive

LEUNG KAI FOOK MEDICAL CO PTE LTD; Singapore; On-site; SGD 45,000 - 60,000; Full time

Job summary

A healthcare organization in Singapore is looking for a Quality Assurance professional to maintain and improve its Quality Management System. This role involves ensuring compliance with regulatory requirements and managing documentation control. The ideal candidate will have a degree in Pharmaceutical Science or Engineering, along with at least 2 years of experience in quality assurance. Strong communication skills and proficiency in Microsoft Office are crucial. This position operates on a 5-day work week, from 8:00 am to 5:15 pm.

Qualifications

• Minimum 2 years of experience in quality assurance.
• Strong knowledge of QMS standards like ISO 9001 and cGMP.
• Proven expertise in QA processes including investigations and audits.

Responsibilities

• Maintain and improve the Quality Management System.
• Serve as document controller for various quality-related documents.
• Ensure compliance with regulatory requirements.

Skills

Quality Management System (QMS)

Quality Assurance (QA)

Documentation Control

Communication Skills

Microsoft Office

Education

Degree in Pharmaceutical Science, Engineering, or related field

Job description

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)