Quality Assurance Executive

Leung Kai Fook Medical Co; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A pharmaceutical and medical devices company in Singapore is seeking a Quality Assurance Specialist to maintain and improve their Quality Management System. Responsibilities include document control, compliance with various regulatory requirements, and handling customer complaints. The ideal candidate holds a degree in Pharmaceutical Science or Engineering and has at least 2 years of experience in quality assurance.

Qualifications

• 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.

Responsibilities

• Maintain and improve the Quality Management System (QMS).
• Serve as the document controller for the Quality Manual and procedures.
• Ensure compliance with GMP, PIC/s, ICH, ASEAN Guidelines, FDA, and regulatory requirements.
• Manage customer complaints, product recalls, and quality issues.

Skills

Quality Management System (QMS)

Documentation control

Interpersonal skills

Change control

Process validation

Excellent follow-up

Education

Degree in Pharmaceutical Science, Engineering, or a related field

Tools

Microsoft Office

Job description

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)