Quality Compliance & QMS Lead

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

Job summary

Recruit Express Pte Ltd is seeking a Quality Compliance professional to support the site Quality Management System (QMS) and ensure compliance with GxP, GMP and regulatory expectations. You will partner with cross-functional teams to strengthen quality standards and inspection readiness.

Responsibilities include maintaining SOPs and documents, leading CAPA activities, coordinating change controls, and supporting audits and quality reviews.

Qualifications

• Experience in Quality Assurance, GMP, GxP within a regulated manufacturing environment.
• Working knowledge of QMS processes including CAPA, change control, document control, audits and compliance management.
• Experience collaborating with cross-functional teams and coordinating quality-related activities.
• Strong organisational skills with a structured and detail-oriented approach to follow-up and documentation.
• Ability to review quality data, identify potential compliance issues and coordinate corrective actions.
• Strong communication and stakeholder management capabilities.
• Proactive mindset with a commitment to regulatory compliance, continuous improvement and maintaining high quality standards.

Responsibilities

• Develop, review and update SOPs, work instructions, policies and other controlled quality documents.
• Support ongoing maintenance and improvement of QMS processes and electronic quality systems in line with GxP and business requirements.
• Coordinate site change controls, including impact assessments, implementation activities and post-implementation effectiveness reviews.
• Manage CAPA activities by monitoring investigations, corrective actions, due dates and effectiveness checks.
• Conduct compliance and quality gap assessments against internal standards, corporate requirements and applicable regulations.
• Maintain effective document and records management processes, including document issuance, archival and retention.
• Coordinate GMP training and personnel qualification programmes, including annual training schedules and relevant training materials.
• Support Product Quality Reviews through data collection, trend analysis and identification of potential quality improvement actions.
• Coordinate internal self-inspection programmes and support follow-up activities arising from audit observations.
• Assist with inspection readiness and coordinate activities related to customer, client and regulatory audits.
• Partner with subject matter experts to investigate audit findings and track commitments to closure.
• Support management review processes by preparing quality metrics, compliance trends and performance reports.
• Provide quality oversight for supplier-related activities, including Quality Agreements, supplier changes and supplier qualification or evaluation.
• Monitor QMS records and follow up with stakeholders to ensure quality events are investigated and closed within timelines.
• Support implementation and maintenance of data integrity practices across site quality processes.
• Promote adherence to site safety requirements, emergency procedures and safe working practices.
• Perform other quality and compliance-related duties as assigned.

Skills

Quality Assurance

GMP/GxP knowledge

QMS CAPA/change control

Cross-functional collaboration

Documentation & records management

Analytical data review

Regulatory compliance mindset

Stakeholder management

Job description

Recruit Express Pte Ltd is seeking a Quality Compliance professional to support the site Quality Management System (QMS) and ensure compliance with GxP, GMP and regulatory expectations. You will partner with cross-functional teams to strengthen quality standards and inspection readiness.

Responsibilities include maintaining SOPs and documents, leading CAPA activities, coordinating change controls, and supporting audits and quality reviews.