Contract QA Associate (Pharma MNC, West) #HHW

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

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).