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 seeking a Quality Assurance Specialist to drive the development, implementation, and continuous improvement of quality systems across GMP-regulated laboratory and manufacturing operations in Singapore. You will author and review critical quality documentation, manage deviations and CAPA, support audits and inspections, and oversee qualification and validation activities for equipment and facilities.

Qualifications

• Postgraduate qualification in Pharmacy, Chemistry, Life Sciences, or related discipline.
• Minimum 4 years of QA experience in GMP/GxP environments.
• Solid understanding of GMP, GLP, GxP, FDA, and HSA requirements.
• Hands-on experience with document control, deviations, CAPA, change control, and training management.
• Proven track record supporting audits and regulatory inspections.
• Experience with qualification and validation projects including protocol and report writing.
• Knowledge of ISO 9001, ISO 17025, data integrity principles and validation lifecycles.

Responsibilities

• Develop, implement, and maintain Quality Management Systems (QMS) in accordance with GMP, GLP, GxP, FDA, HSA, and relevant quality standards.
• Author, review, and manage quality documentation including SOPs, work instructions, protocols, reports, and quality manuals.
• Oversee 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 (IQ, OQ, PQ).
• Manage quality records, archival systems, and master schedules with data integrity in mind.
• Lead or support internal and regulatory audits and inspections, driving inspection readiness and CAPA implementation.
• Assist in establishing and maintaining quality systems for GMP cleanroom operations, including environmental monitoring.

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 experienced Quality 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