As a QC specialist supporting our clinical trials in Singapore and abroad, you will be part of a team responsible for ensuring patient safety through testing of our therapeutic product and its intermediates. You will also be expected to actively participate in assay development and validation, as well as in OOS, RCA, CAPA implementation, and may be called upon to perform additional duties in support of the company’s cGMP activities.
Responsibilities
- To conduct in-process QC tests and final product release tests
- To perform method validation on flow cytometry and qPCR methods.
- To maintain and clean QC laboratory equipment routinely.
- To complete QC records of testing process and results
- To analyse and review test results, procedures, and reports
- To create SOP, test reports and logbooks
- To execute environmental monitoring program of clean areas
- To track events and trend data accumulated from test reports
- To assist in the development of new assay methods
- To support in change control, deviation, OOS, CAPA, RCA
- To comply with cGMP/GDP requirements
Requirements
- Professional experience with flow cytometry, qPCR, cell culture, immunology and assay development/validation
- A bachelor’s degree in biomedical science, microbiology, cell biology or equivalent
- Minimum 1 years’ relevant laboratory experience, fresh graduate will be considered
- GMP experience is a plus
