12m Quality Management System Specialist #HFT

Job Overview

The Quality Management System Specialist will support the maintenance and continuous improvement of the site's Quality Management System (QMS), ensuring that quality processes, documentation, training and compliance activities are effectively implemented in accordance with applicable GxP, GMP and regulatory requirements.

The role will work closely with cross-functional teams to manage quality systems, site compliance activities, audits, documentation, training and continuous improvement initiatives.

Key Responsibilities

Quality Management System & Documentation

• Develop, author and review Standard Operating Procedures (SOPs), Work Instructions and other QMS-related documentation.
• Maintain and support QMS platforms, including TrackWise, eDMS, SFLMS or equivalent systems.
• Ensure QMS processes and systems are configured and maintained to support GxP compliance.
• Maintain the site document and record management system and ensure documents are executed and maintained in accordance with site requirements.
• Coordinate record archival activities and ensure relevant C&Q execution records are properly archived.

Change Control & CAPA

• Maintain the site change control system and coordinate the assessment, implementation and closure of change controls.
• Develop and maintain effective change control evaluation methodologies.
• Maintain the site Corrective and Preventive Action (CAPA) system.
• Support the development of appropriate corrective and preventive actions and effectiveness checks.
• Monitor CAPA and other QMS activities to ensure timely completion and prevent overdue records.

Compliance & Audit Readiness

• Conduct site-level gap assessments against corporate standards and applicable regulatory requirements.
• Develop and coordinate the annual site self-inspection programme.
• Coordinate and participate in self-inspections, periodic reviews and compliance trend analysis.
• Support the development and qualification of site GMP auditors.
• Coordinate inspection-readiness activities to ensure ongoing readiness for client and regulatory audits.
• Support client and regulatory audits and coordinate responses to audit findings and commitments.
• Work with subject matter experts across functional teams to ensure timely and effective closure of audit findings.

Training & Personnel Qualification

• Maintain the site's GMP training system and coordinate training activities across functions.
• Develop annual training plans and support the development and enhancement of GMP training modules.
• Coordinate personnel qualification activities and monitor completion of required training.
• Work with cross-functional training representatives to ensure training requirements are effectively implemented.

Product Quality & Management Review

• Develop and execute the annual Product Quality Review (PQR) plan.
• Conduct product quality reviews and perform relevant trend analysis.
• Identify quality trends and coordinate appropriate CAPA or continuous improvement activities.
• Support site management review processes through collection and analysis of quality data and compliance metrics.
• Monitor quality performance indicators and identify opportunities for continuous improvement.

Supplier Quality Management

• Provide quality oversight for the site's supplier management programme.
• Manage Quality Agreements and supplier change controls.
• Participate in material certification activities and supplier selection/evaluation as the quality representative.
• Coordinate with relevant stakeholders to ensure supplier-related quality requirements are met.

Data Integrity & Continuous Improvement

• Maintain the site's data integrity system and support effective implementation across relevant functions.
• Monitor QMS events and ensure timely closure within established due dates.
• Analyse compliance and quality trends and recommend appropriate improvement initiatives.
• Support other quality-related projects and activities as assigned.

Safety & Other Responsibilities

• Promote adherence to applicable safety requirements and safe systems of work.
• Understand and comply with emergency procedures and workplace safety requirements.
• Perform other relevant duties and projects assigned by management.

Requirements

• Diploma or Degree in Quality Management, Life Sciences, Pharmaceutical Sciences, Chemistry, Biotechnology or a related discipline.
• Relevant experience in Quality Assurance, Quality Management Systems, GMP or a regulated manufacturing environment.
• Hands-on experience with QMS processes such as CAPA, change control, document control, audit management and training systems.
• Good understanding of GxP, GMP and applicable regulatory requirements.
• Experience in SOP authoring, review and document management.
• Experience supporting internal, client or regulatory audits and inspection readiness activities.
• Experience with electronic QMS/document management systems such as TrackWise, eDMS, SFLMS or equivalent will be advantageous.

For interested candidates, please submit your latest resume to [email protected]

Jacqueline Fong Hsin Ting (R21103226)
Recruit Express Pte Ltd
Company Reg. No. 199601303W
EA License Number: 99C4599