Quality Assurance Specialist

Position Overview

The Quality Assurance Specialist will establish, maintain and continuously improve the Quality Management System for a research laboratory in Singapore, in line with international standards including FDA CMC/HSA, GLP/GMP, GxP, ISO 9001 and ISO 17025. You will support the day-to-day running of the laboratory through quality documentation, staff training, document control, supplier oversight, risk assessment, validation and the management of quality schedules and records. The role also supports the setup of a new GMP facility, extending existing laboratory systems to cover cleanroom operations. The site is in an expansion phase, with a higher standard of QA compliance being rolled out across the facility.

Key Responsibilities

R&D Laboratory

• Establish and maintain the laboratory QMS in accordance with GLP/GMP and FDA/HSA requirements
• Draft, review and implement QMS documentation, including SOPs, work instructions, laboratory protocols and manuals
• Train staff on QMS activities, such as SOP implementation
• Ensure SOPs are technically valid, approved and followed
• Manage core QMS processes (deviations, CAPA and change control), driving timely and robust closure
• Set up and manage the archive and document control system, including indexing and filing of current and superseded documents, in line with ALCOA+ data integrity principles
• Establish and manage a Master Schedule for all activities supporting studies in the facility
• Conduct due diligence on and manage contractors and third-party suppliers
• Host audits and inspections, acting as lead contact for third-party auditors and inspectors
• Perform risk assessments, and manage and execute validation schedules and protocols to qualify, validate and maintain laboratory equipment

GMP Facility

• Support the establishment and implementation of the GMP QMS for the new facility, extending existing systems to cover GMP-classified (cleanroom) operations
• Support qualification and validation of facilities, utilities and equipment (URS, DQ, IQ, OQ, PQ) in line with Annex 15 and ICH Q7, including authoring and executing protocols and reports and maintaining the validation status register
• Review vendor documentation (e.g. Basis of Design, FAT/SAT, turnover packages) as part of supplier qualification
• Support classification, commissioning and environmental monitoring of cleanroom areas, and contribute to the contamination control strategy and cleaning/sanitisation validation
• Support GMP audits and inspection readiness for the new facility

Required Qualifications

• Postgraduate qualification in Pharmacy, Chemistry or a related discipline
• At least 4 years' experience in an accredited or GMP-regulated facility, with strong working knowledge of GxP and FDA/HSA GMP requirements
• Working knowledge of ISO 9001 and ISO 17025
• Demonstrated experience managing core QMS processes: document control, deviations, CAPA and change control
• Demonstrated experience with government inspections, including inspection readiness and CAPA implementation
• Hands-on experience in qualification and validation (IQ/OQ/PQ), with strong technical writing skills for protocols, reports and SOPs
• Preferred: cleanroom/classified environment experience (commissioning, environmental monitoring, contamination control)
• Preferred: experience in a GMP facility manufacturing finished products
• Preferred: familiarity with EU GMP Annex 15, ICH Q7, computerised system validation (Annex 11 / GAMP 5) and data integrity

Why join us?

• Generous Leave Policy.
• Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
• Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
• Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
• Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.

How to apply

Are you ready to play a key role in shaping the future of pharmaceutical solutions? If you're passionate about making an impact, we want you on our team!

Please submit your resume, outlining your qualifications and experience relevant to the role, here.