We are seeking a detail-oriented and proactive Associate II, Quality Assurance Compliance to support the implementation and maintenance of the Quality Management System (QMS) at our Singapore site. This role plays a key part in ensuring compliance with quality standards, customer requirements, and applicable regulatory expectations while maintaining inspection readiness and supporting continuous improvement initiatives.

The successful candidate will work closely with cross-functional teams to ensure the effective operation of quality systems, promote data integrity, and support compliance with global quality standards and regulatory requirements.

Key Responsibilities

• Compile, analyze, and report quality metrics to support Management Review meetings.
• Coordinate and prepare Annual Product Quality Review (APQR) reports.
• Support document control activities, Quality Management System (QMS) maintenance, and artwork review processes.
• Coordinate inspection readiness activities, including preparation for internal audits and regulatory inspections.
• Track and coordinate responses to inspection observations, ensuring timely implementation and closure of corrective actions.
• Review and approve change controls to ensure compliance with internal procedures and regulatory expectations.
• Ensure compliance with Good Manufacturing Practice (GMP), ISO 13485, MDSAP, EU MDR, and local regulatory requirements.
• Identify and support continuous improvement initiatives to enhance quality systems and compliance processes.
• Collaborate with cross-functional stakeholders to maintain effective quality management processes.

Requirements

Education

• Degree in Pharmacy, Chemistry, Biotechnology, Life Sciences, or a related discipline.

Experience

• Minimum 2 years of Quality Assurance or Quality Compliance experience within the pharmaceutical and/or medical device industry.

• Working knowledge of Quality Management Systems (QMS) and Good Manufacturing Practice (GMP).
• Familiarity with ISO 13485, MDSAP, EU MDR, and local regulatory requirements (e.g. HSA).

For interested candidates, please submit your latest resume to

[email protected]

Wendy Khoo Hui Wen (R1761665)

Recruit Express Pte Ltd

Company Reg. No. 199601303W

EA License Number: 99C4599