Quality Systems & Compliance Specialist #HDC1

The Role Be part of a quality-focused team where you will play a key role in maintaining and strengthening the site’s Quality Management System (QMS), ensuring compliance with GxP, GMP and applicable regulatory requirements. You will work closely with cross-functional teams to drive quality initiatives, support audit readiness and promote continuous improvement across the site. Key Responsibilities Develop, review and maintain SOPs, work instructions and other quality-related procedures.

Maintain and improve QMS platforms and systems, ensuring they support GxP compliance and operational requirements.

Manage site change control activities, including impact assessments, implementation and effectiveness monitoring.

Oversee the CAPA system, ensuring appropriate corrective actions are implemented, completed on time and effectively verified.

Conduct site-level gap assessments against corporate standards and regulatory requirements.

Oversee document and record management processes, including document control, archival and record retention activities.

Manage GMP training and personnel qualification processes, including the development of annual training plans and GMP training modules.

Coordinate Product Quality Reviews, including data trending and identification of appropriate CAPAs.

Plan and execute site self-inspection programmes, including audit participation, trend analysis and continuous compliance improvement.

Coordinate inspection-readiness activities and support client and regulatory audits.

Work with cross-functional subject matter experts to manage audit findings and ensure timely completion of commitments.

Support management review activities through quality data collection, compliance trend analysis and performance metrics.

Provide quality oversight for supplier management, including Quality Agreements, supplier change controls and supplier evaluations.

Monitor QMS events and ensure timely closure without overdue records.

Support the implementation and maintenance of site data integrity requirements.

Promote a strong safety culture and ensure compliance with emergency procedures and safe systems of work.

Undertake other quality-related responsibilities as assigned.

What You’ll Bring Relevant experience in Quality, Quality Systems, GMP, GxP or a regulated manufacturing environment.

Good understanding of QMS, CAPA, change control, document control and audit processes.

Experience working with cross-functional stakeholders and managing quality-related activities.

Strong attention to detail with good organisational and follow-up skills.

Ability to analyse quality data, identify compliance gaps and drive appropriate corrective actions.

Good communication and stakeholder management skills.

A proactive approach towards compliance, continuous improvement and quality excellence.

📩  Interested candidates may apply by sending their CV to: leonleong@recruitexpress.com.sg EA Licence Details: Leon Leong De Cong R1551708 Recruit Express Pte Ltd EA License No. 99C4599