QA & Compliance Specialist – QMS & GMP

Recruit Express Pte Ltd; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

Recruit Express Pte Ltd in Singapore is seeking an Associate II, Quality Assurance Compliance to support the QMS, ensuring GMP/ISO 13485 compliance, and assisting with APQR preparation, audits, and change controls. The role emphasizes data integrity, inspection readiness, and alignment with regulatory expectations.

You will collaborate with cross-functional teams to maintain effective quality management processes and drive continuous improvement initiatives within the site.

Qualifications

• Minimum 2 years of Quality Assurance or Quality Compliance experience in pharma/medical device.
• Working knowledge of QMS and GMP.
• Familiarity with ISO 13485, MDSAP, EU MDR and local regulatory requirements (e.g. HSA).

Responsibilities

• Compile, analyze, and report quality metrics for Management Review meetings.
• Coordinate and prepare APQR reports.
• Support document control activities, QMS maintenance, and artwork reviews.
• Coordinate inspection readiness activities, including internal audits and regulatory inspections.
• Track and coordinate responses to inspection observations and close corrective actions.
• Review and approve change controls to ensure compliance with procedures and regulations.
• Ensure compliance with GMP, ISO 13485, MDSAP, EU MDR and local requirements.
• Identify and support continuous improvement initiatives for quality systems.
• Collaborate with cross-functional stakeholders to maintain effective quality processes.

Skills

QMS

Change controls

GMP

ISO 13485

MDSAP

EU MDR

Regulatory compliance

APQR

Document control

Continuous improvement

Inspection readiness

Data integrity

Cross-functional collaboration

Education

Degree in Pharmacy, Chemistry, Biotechnology, Life Sciences, or related

Job description

Recruit Express Pte Ltd in Singapore is seeking an Associate II, Quality Assurance Compliance to support the QMS, ensuring GMP/ISO 13485 compliance, and assisting with APQR preparation, audits, and change controls. The role emphasizes data integrity, inspection readiness, and alignment with regulatory expectations.

You will collaborate with cross-functional teams to maintain effective quality management processes and drive continuous improvement initiatives within the site.