Quality Assurance Specialist

PHAIDON INTERNATIONAL (SINGAPORE) PTE. LTD.; Singapore; On-site; SGD 70,000 - 110,000; Full time

Job summary

PHAIDON INTERNATIONAL (SINGAPORE) PTE. LTD. is a leading life sciences and healthcare company in Singapore, expanding its research, development and manufacturing capabilities.

We are seeking an experienced Quality Assurance Specialist to support the development, implementation and continuous improvement of quality systems across GMP-regulated operations. Responsibilities include creating and maintaining QMS in compliance with GxP, GMP, GLP, and regulatory standards; authoring SOPs and documents;

Qualifications

• Postgraduate qualification in Pharmacy, Chemistry, Life Sciences, or a related scientific discipline.
• Minimum 4 years of quality assurance experience within a GMP-regulated, accredited, or GxP-compliant environment.
• Strong understanding of GMP, GLP, GxP, FDA, and HSA regulatory requirements.
• Hands-on experience managing document control, deviations, CAPA, change control, and quality system processes.
• Proven experience supporting audits, regulatory inspections, and remediation activities.
• Demonstrated involvement in qualification and validation projects, including protocol and report authoring.
• Working knowledge of ISO 9001, ISO 17025, data integrity principles, and validation lifecycle requirements.

Responsibilities

• Develop, implement, and maintain Quality Management Systems (QMS) in compliance with GxP, GMP, GLP, FDA, HSA, and relevant quality standards.
• Author, review, and manage quality documentation including SOPs, work instructions, protocols, reports, and quality manuals.
• Oversee key quality processes such as document control, deviations, CAPA, change control, and training management.
• Coordinate supplier qualification activities, contractor oversight, and quality-related risk assessments.
• Support qualification and validation of laboratory equipment, facilities, utilities, and systems, including IQ, OQ, and PQ activities.
• Manage quality records, archival systems, and master schedules while ensuring compliance with data integrity requirements.
• Lead or support internal, external, regulatory audits and inspections, driving inspection readiness and CAPA implementation.
• Assist in the establishment and maintenance of quality systems for GMP cleanroom operations, including environmental monitoring and contamination control initiatives.

Skills

Quality Assurance

GxP

GMP

GLP

FDA

HSA

Document control

CAPA

Change control

Audits

Validation

Data integrity

Education

Pharmacy

Chemistry

Life Sciences

Job description

Our client is a leading life sciences and healthcare organization expanding its research, development, and manufacturing capabilities in Singapore. As part of its continued growth, the company is seeking an experiencedQuality Assurance Specialist to support the development, implementation, and continuous improvement of quality systems across laboratory and GMP-regulated operations.

Responsibilities

• Develop, implement, and maintain Quality Management Systems (QMS) in compliance with GxP, GMP, GLP, FDA, HSA, and relevant quality standards.
• Author, review, and manage quality documentation including SOPs, work instructions, protocols, reports, and quality manuals.
• Oversee key quality processes such as document control, deviations, CAPA, change control, and training management.
• Coordinate supplier qualification activities, contractor oversight, and quality-related risk assessments.
• Support qualification and validation of laboratory equipment, facilities, utilities, and systems, including IQ, OQ, and PQ activities.
• Manage quality records, archival systems, and master schedules while ensuring compliance with data integrity requirements.
• Lead or support internal, external, regulatory audits and inspections, driving inspection readiness and CAPA implementation.
• Assist in the establishment and maintenance of quality systems for GMP cleanroom operations, including environmental monitoring and contamination control initiatives.

Requirements

• Postgraduate qualification in Pharmacy, Chemistry, Life Sciences, or a related scientific discipline.
• Minimum 4 years of quality assurance experience within a GMP-regulated, accredited, or GxP-compliant environment.
• Strong understanding of GMP, GLP, GxP, FDA, and HSA regulatory requirements.
• Hands-on experience managing document control, deviations, CAPA, change control, and quality system processes.
• Proven experience supporting audits, regulatory inspections, and remediation activities.
• Demonstrated involvement in qualification and validation projects, including protocol and report authoring.
• Working knowledge of ISO 9001, ISO 17025, data integrity principles, and validation lifecycle requirements.

Preferred Experience

• Exposure to cleanroom operations, environmental monitoring, and contamination control programs.
• Experience supporting GMP manufacturing facilities and product production environments.
• Familiarity with EU GMP Annex 15, ICH Q7, Annex 11, and GAMP 5 requirements.
• Knowledge of computerized system validation and data integrity compliance