QA Compliance Lead - GMP, CAPA & QMS Excellence

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

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.