Quality Management System Specialist - GMP & Quality Systems #HDC1

Recruit Express Pte Ltd; Singapore; On-site; SGD 70,000 - 110,000; Full time

Job summary

Recruit Express Pte Ltd is seeking a Quality Assurance professional to own QMS processes, drive compliance, and enable continuous improvement across site operations.

You will develop and maintain SOPs and controlled documents, manage QMS platforms, oversee CAPA and Change Control, coordinate audits, and provide quality oversight for supplier management and inspections to ensure GMP readiness. Join a dynamic team focused on safety, data integrity and regulatory excellence.

Qualifications

• Relevant experience in Quality Assurance, Quality Management Systems, GMP or a related regulated environment.
• Strong understanding of QMS processes such as CAPA, Change Control, Document Control, Training, Audit and Inspection Readiness.
• Good analytical, documentation and stakeholder management skills.
• Ability to work independently while collaborating effectively with cross-functional teams.
• Strong attention to detail with a proactive approach to compliance and continuous improvement.

Responsibilities

• Develop, review and maintain SOPs, work instructions and other controlled quality documents across functional teams.
• Manage and maintain QMS platforms and systems to support GxP compliance.
• Oversee site Change Control and CAPA processes, ensuring appropriate assessment, timely execution and effective closure.
• Conduct gap assessments against corporate standards and regulatory requirements, driving corrective actions where required.
• Manage document and records control processes, including archival and compliance of executed records.
• Oversee GMP training and personnel qualification programmes, including the development of annual training plans and training modules.
• Coordinate Product Quality Reviews (PQR) , including trend analysis and follow-up CAPA activities.
• Plan and execute site self-inspection programmes, supporting continuous improvement and strengthening GMP compliance.
• Coordinate inspection-readiness activities and support client and regulatory audits.
• Work closely with subject matter experts across functions to address audit findings and ensure commitments are completed effectively and on time.
• Support management review activities through quality data collection, metrics tracking, compliance trend analysis and continuous improvement initiatives.
• Provide quality oversight for supplier management activities, including Quality Agreements, supplier change controls, material certification and supplier evaluations.
• Monitor QMS events and ensure timely closure with no overdue records.
• Maintain site data integrity systems and support effective implementation across the site.
• Promote a strong safety culture and ensure adherence to emergency procedures and safe working practices.
• Undertake other quality-related responsibilities and projects as assigned.

Skills

Quality Assurance

GMP

QMS

CAPA

Change Control

Documentation

Job description

Be part of a dynamic quality team supporting a robust GxP and GMP quality environment . This role offers the opportunity to take ownership of key Quality Management System (QMS) processes, drive compliance initiatives and contribute to continuous improvement across site operations.

What You'll Be Doing

• Develop, review and maintain SOPs, work instructions and other controlled quality documents across functional teams.
• Manage and maintain QMS platforms and systems to support GxP compliance.
• Oversee site Change Control and CAPA processes, ensuring appropriate assessment, timely execution and effective closure.
• Conduct gap assessments against corporate standards and regulatory requirements, driving corrective actions where required.
• Manage document and records control processes, including archival and compliance of executed records.
• Oversee GMP training and personnel qualification programmes, including the development of annual training plans and training modules.
• Coordinate Product Quality Reviews (PQR) , including trend analysis and follow-up CAPA activities.
• Plan and execute site self-inspection programmes, supporting continuous improvement and strengthening GMP compliance.
• Coordinate inspection-readiness activities and support client and regulatory audits.
• Work closely with subject matter experts across functions to address audit findings and ensure commitments are completed effectively and on time.
• Support management review activities through quality data collection, metrics tracking, compliance trend analysis and continuous improvement initiatives.
• Provide quality oversight for supplier management activities, including Quality Agreements, supplier change controls, material certification and supplier evaluations.
• Monitor QMS events and ensure timely closure with no overdue records.
• Maintain site data integrity systems and support effective implementation across the site.
• Promote a strong safety culture and ensure adherence to emergency procedures and safe working practices.
• Undertake other quality-related responsibilities and projects as assigned.

What You'll Bring

• Relevant experience in Quality Assurance, Quality Management Systems, GMP or a related regulated environment .
• Strong understanding of QMS processes such as CAPA, Change Control, Document Control, Training, Audit and Inspection Readiness.
• Good analytical, documentation and stakeholder management skills.
• Ability to work independently while collaborating effectively with cross-functional teams.
• Strong attention to detail with a proactive approach to compliance and continuous improvement.