Quality Compliance & QMS Specialist #HDC1

Drive Quality Compliance & Strengthen Site Quality Systems Join a quality-driven team where you will support the effective operation and continuous enhancement of the site’s Quality Management System (QMS). In this role, you will help ensure compliance with GxP, GMP and relevant regulatory expectations while partnering with teams across the organisation to strengthen quality standards and inspection readiness. Key Responsibilities • Develop, review and update SOPs, work instructions, policies and other controlled quality documents. • Support the 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 relevant subject matter experts to investigate audit findings and track commitments through to timely closure. • Support management review processes by preparing quality metrics, compliance trends and relevant 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 appropriately investigated and closed within established timelines. • Support the implementation and ongoing 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. What You’ll Bring • Relevant experience in Quality Assurance, Quality Systems, GMP, GxP or 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 appropriate corrective and preventive actions. • Strong communication and stakeholder management capabilities. • Proactive mindset with a commitment to regulatory compliance, continuous improvement and maintaining high quality standards. 📩 Interested candidates may apply by sending your CV to: leonleong@recruitexpress.com.sg EA Licence Details: Leon Leong De Cong R1551708 Recruit Express Pte Ltd EA License No. 99C4599