Quality Assurance Executive

Leung Kai Fook Medical Co Pte Ltd; Singapore; On-site; SGD 40,000 - 60,000; Full time

Job summary

A pharmaceutical company based in Singapore is looking for a Quality Assurance Specialist. Responsibilities include maintaining the Quality Management System, ensuring compliance with regulatory standards, managing customer complaints, and handling quality issues in manufacturing. Candidates should have a degree in Pharmaceutical Science or Engineering, with at least 2 years of relevant experience and strong knowledge of QMS and QA processes. Proficiency in Microsoft Office is required.

Qualifications

• At least 2 years of experience in quality assurance within pharmaceuticals or manufacturing.
• Proven expertise in QA processes including investigations, change control, and audits.
• Hands-on experience in documentation control and implementation.

Responsibilities

• Maintain and improve the Quality Management System (QMS).
• Serve as the document controller for various quality documentation.
• Ensure compliance with GMP, FDA, and other regulatory requirements.
• Manage customer complaints, product recalls, and quality issues.

Skills

Strong knowledge of QMS

Excellent follow-up

Communication skills

Interpersonal skills

Meticulous and well-organised

Detail-oriented

Proficient in Microsoft Office

Education

Degree in Pharmaceutical Science

Degree in Engineering

Degree in a 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.

We regret to inform you that only shortlisted candidates will be notified.