Research Assistant (Quality Assurance)
Job Description
The National University of Singapore invites applications for Research Assistant (Quality Assurance (QA) Executive) in the Clinical Imaging Research Centre (CIRC), Yong Loo Lin School of Medicine. CIRC is a dedicated molecular imaging research centre. It is equipped with on-site capability for the preparation of PET radiopharmaceuticals in a state-of-the-art GMP-certified facility. CIRC is positioned to support both academic and commercially led clinical research programs, with dedicated clinical imaging facilities area advanced modalities of PET-CT and PET-MRI. For more details on what we do, do visit https://medicine.nus.edu.sg/circ/. Appointments will be made on a two-years contract basis with the possibility of extension.
Purpose of the post
This role provides QA support across document control, batch record management, training records, supplier documentation, audits, and quality system activities. Responsibilities include maintaining quality registers, tracking due dates and CAPA actions, supporting Bizzmine eQMS document control, checking Batch Manufacturing Records for completeness, and assisting with QA reporting and trending. Also supports GMP training, supplier qualification records, inspection readiness, and maintenance of key controlled documents. In addition, the role contributes to QA improvement work and is being trained to support investigational radiopharmaceutical release as an Authorised Person under supervision.
Main duties and responsibilities
The QA Executive will be able to:
- Provide OMS Support – maintain and update registers
- Assist in document management & eQMS (Bizzmine)
- Support Batch Record (BMR) & QA Operations
- Assist, arrange & support training and filing of training records, especially the annual GMP training
- Assist & support in maintaining supplier and material documentation
- Assist & support during audit & inspection period
- Assist in QA related improvement projects and digital quality system activities
- To take up the role of Authorised Person for the release of investigational radiopharmaceuticals in compliance with PIC/S GMP (Under supervision)
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