Quality Systems & Compliance Specialist #HDC1

Recruit Express Pte Ltd; Singapore; On-site; SGD 70,000 - 95,000; Full time

Job summary

Recruit Express Pte Ltd seeks a Quality Assurance professional to maintain and strengthen the site’s QMS, ensuring GxP and GMP compliance and regulatory alignment.

You will collaborate with cross-functional teams to drive quality initiatives, support audit readiness, CAPA, change controls, document control, and continuous improvement across the site.

Qualifications

• Experience in Quality, Quality Systems, GMP or GxP in a regulated manufacturing environment.
• Strong knowledge of CAPA, change control, documentation and audits.
• Experience collaborating with cross-functional teams.
• Detail-oriented with excellent organizational skills.
• Ability to analyze quality data and drive corrective actions.

Responsibilities

• Develop, review and maintain SOPs, work instructions and other quality-related procedures.
• Maintain and improve QMS platforms and systems for GxP compliance and operations.
• Manage site change control activities, including impact assessments and effectiveness monitoring.
• Oversee the CAPA system and ensure timely, verified actions.
• Conduct site-level gap assessments against corporate standards and regulatory requirements.
• Oversee document and record management, including control, archival and retention.
• Manage GMP training and qualification processes, including annual training plans.
• Coordinate Product Quality Reviews with data trending and CAPA identification.
• Plan and execute site self-inspection programmes, including audit participation and trend analysis.
• Coordinate inspection-readiness activities and support client/regulatory audits.
• Work with cross-functional SMEs to manage audit findings and commitments.
• Support management review activities with quality data and metrics.
• Provide quality oversight for supplier management and supplier evaluations.
• Monitor QMS events and ensure timely closure of records.
• Support data integrity requirements within the site.
• Promote a strong safety culture and compliance with emergency procedures.

Skills

Quality management

Quality systems

GxP/GMP compliance

CAPA

Change control

Document control

Audit readiness

Cross-functional collaboration

Data analysis

Attention to detail

Job description

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.