QA Officer (Ref. CNRM2026-013)

Center for Neuromusculoskeletal Restorative Medicine (CNRM) Limited

CNRM based at the Hong Kong Science and Technology Park (HKSTP), combines the talents and expertise in stem cells, biomaterials, 3D bioprinting, tissue engineering, and personalized and translational medicine from The Chinese University of Hong Kong (CUHK).

The Center is a multi-disciplinary, international consortium devoted to the application of convergent principles and technologies of biomedical science and engineering to restore structure and function to neuromusculoskeletal tissues and organs injured, diseased and degenerated due to aging, for the maintenance of mobility and enhancement of quality of life through biomedical research and development.

We are seeking a QA Officer to join our QA team. The QA Officer provides operational support to the QA team in maintaining the Pharmaceutical Quality System for Advanced Therapy Products manufacturing. The role focuses on day-to-day compliance activities, documentation, and quality records in a PIC/S GMP environment.

Key Responsibilities:

1. Draft, review, distribute, and archive QA SOPs and execution records.
2. Monitor site-wide periodic document reviews.
3. Track GMP training progress, maintain training matrices, and archive training files.
4. Facilitate Deviations, CAPAs, Change Controls, and Quality Risk Management (QRM) assessments.
5. Assist with self-inspections, internal audits, and regulatory inspection readiness.
6. Evaluate raw material suppliers, outsourced service vendors, and maintain the Approved Supplier List.
7. Assist in reviewing equipment, utility, and facility qualification protocols.

Job requirements:

1. Bachelor’s degree in Life Sciences, Biotechnology, Pharmacy, or related field.
2. 1-2 years of Quality Assurance experience in a PIC/S GMP-regulated facility; experience in cell therapy or advanced therapy products is preferred.
3. Familiarity with PIC/S GMP guidelines, particularly Part 1 and Annex 1.
4. Detail-oriented with strong analytical and problem-solving skills; Good verbal and written communication skills in English and Chinese; Proactive, organized, and capable of managing multiple priorities in a GMP-regulated setting.

The appointment will initially be made on a contract basis commencing as soon as possible, renewable subject to good performance and mutual agreement.

The information provided will be kept confidential and only be used for those purposes relating to your application. We are an equal opportunities employer and welcomes applications from all qualified candidates.