Research Assistant (Quality Assurance)

National University of Singapore; Singapore; On-site; SGD 42,000 - 64,000; Full time

Job summary

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 with GMP-certified facilities for PET radiopharmaceuticals.

The QA Executive will support document control, batch records, training records, supplier documentation, audits and quality-system activities, and assist with QA reporting and trend

Qualifications

• Bachelor’s degree and relevant discipline required.
• Experience in PET radiochemistry facility desirable.
• GMP/PIC/S GMP experience strongly preferred.
• Good documentation practices (GDP) and PIC/S GMP understanding.
• Strong organizational and project planning skills in a regulated environment.

Responsibilities

• Provide OMS support – maintain and update registers.
• Assist in document management & eQMS (Bizzmine).
• Support Batch Record (BMR) & QA Operations.
• Assist and support training and filing of training records, especially GMP training.
• Assist and support supplier and material documentation.

Skills

GMP knowledge

Radiopharmaceuticals

Documentation

Project coordination

Communication

Education

Bachelor’s degree (Honours) in Pharmaceutical Science

Tools

eQMS (Bizzmine)

Job description

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:

1. Provide OMS Support – maintain and update registers
2. Assist in document management & eQMS (Bizzmine)
3. Support Batch Record (BMR) & QA Operations
4. Assist, arrange & support training and filing of training records, especially the annual GMP training
5. Assist & support in maintaining supplier and material documentation
6. Assist & support during audit & inspection period
7. Assist in QA related improvement projects and digital quality system activities
8. To take up the role of Authorised Person for the release of investigational radiopharmaceuticals in compliance with PIC/S GMP (Under supervision)

Qualifications

The applicant should:

1. Have a minimum of bachelor’s degree (Honours) or higher in Pharmaceutical Science, Chemistry, LifeSciencesor related discipline;
2. Previousexperience working in a PET radiochemistry facility is highly desirable.
3. Typically,1-3years of relevant experience in QA/QC/QMS in a regulated environment (GMP/PIC/S GMP experience is strongly preferred).
4. Excellent understanding of radiochemical and radiopharmaceutical processes, including material flows, quality controls, and critical parameters in GMP environments.
5. Strong organizational and project planning skills, with the ability to manage multiple tasks and priorities in a regulated environment.
6. Working knowledge of GMP principles and their application to equipment qualification, maintenance, and facility operations.
7. Understanding of radiation safety principles and engineered controls for radioactive materials.
8. Excellent communication and teamwork skills, with a collaborative approach to problem-solving across scientific, quality, and engineering disciplines.
9. Working knowledge ofPIC/S GMPand good documentation practices (GDP).
10. Strong coordination skills; able to follow up across teams and manage multiple deadlines.
11. Comfortable working with digital systems (experience witheQMSisadvantageous).
12. Clear written communication, with strong attention to detail and integrity in a GMP environment
13. Need to beadaptable and flexible to perform required tasks beyond the job description
14. Willing to accept exposureoflow radiation levels (radiopharmaceutical manufacturing)& enter clean room/rotational function.

Remuneration will be commensurate with the candidate’s qualifications and experience. Informal enquiries are welcome and should be made to Ms Emmalyn Chan Mei Mei at ••••@nus.edu.sg.

We regret that only shortlisted candidates will be notified.