Quality Assurance Executive

LEUNG KAI FOOK MEDICAL CO PTE LTD; Singapore; On-site; SGD 45,000 - 65,000; Full time

Job summary

A pharmaceutical company in Singapore seeks a Quality Assurance Specialist to maintain and enhance their Quality Management System. The ideal candidate has at least 2 years of experience in quality assurance within pharmaceuticals or medical devices, with strong knowledge of QMS and documentation control. Responsibilities include ensuring compliance with regulatory requirements and managing customer complaints.

Qualifications

• At least 2 years of experience in quality assurance within the pharmaceuticals, manufacturing, or medical devices.
• Strong knowledge of QMS including documentation control and implementation.
• Proven expertise in QA processes including investigations, change control, and CAPA management.

Responsibilities

• Maintain and continuously improve the QMS.
• Serve as the document controller for the Quality Manual and other documentation.
• Ensure compliance with GMP and other regulatory requirements.
• Conduct process deviation investigations and follow up on CAPA implementation.
• Manage customer complaints and product recalls.

Skills

QMS knowledge

Excellent communication

Attention to detail

Proficiency in Microsoft Office

Education

Degree in Pharmaceutical Science, Engineering, or related field

Job description

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)