Quality Assurance Specialist

About the role

The Quality Assurance Specialist establishes, maintains and continuously improves the Quality Management System of a research laboratory in Singapore, in line with international standards such as FDA CMC/HSA, GLP/GMP, GxP, ISO 9001 and ISO 17025. The role covers quality documentation, staff training, document control, supplier oversight, risk assessment, validation and quality schedules and records, and also supports the setup of a new GMP facility covering cleanroom operations.

Key responsibilities

• R&D laboratory: set up and maintain the QMS under GLP/GMP and FDA/HSA requirements, draft and implement SOPs, protocols and manuals, train staff and ensure SOPs are valid and followed
• Manage core QMS processes (deviations, CAPA, change control), set up the document control system and run the master schedule for study activities
• Manage contractors and suppliers, host audits and inspections, and perform risk assessments and validation of equipment
• GMP facility: support the GMP QMS, qualification and validation of facilities, utilities and equipment (URS, DQ, IQ, OQ, PQ) and vendor qualification
• Support cleanroom classification, commissioning, environmental monitoring, contamination control and cleaning/sanitisation validation, and GMP audit readiness

Required profile

• Postgraduate qualification in Pharmacy, Chemistry or a related discipline
• At least 4 years' experience in an accredited or GMP-regulated facility with strong GxP and FDA/HSA GMP knowledge
• Demonstrated experience managing document control, deviations, CAPA and change control, and with government inspections
• Hands-on qualification and validation experience (IQ/OQ/PQ) and strong technical writing skills
• Preferred: cleanroom experience, finished product manufacturing experience, and familiarity with EU GMP Annex 15, ICH Q7, Annex 11/GAMP 5 and data integrity

Required skills

• Working knowledge of ISO 9001 and ISO 17025
• Technical writing of protocols, reports and SOPs

What we offer

• Generous leave policy
• Comprehensive medical and dental coverage
• Professional development opportunities