The posting
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: [email protected]
EA Licence Details: Leon Leong De Cong R1551708 Recruit Express Pte Ltd EA License No. 99C4599



