QC/QA Officer

Job Responsibilities:

- Support superior in managing day-to-day operating expenditures against operating budgets to ensure efficient usage of resources.

- Support the design and development of quality procedures, processes, and standards to ensure alignment to quality policy and local regulatory guidelines.

- Provide technical assistance to production on quality and process improvements and perform troubleshooting when necessary.

- Responsible to write and/or update all relevant documentation for project activities.

- Support quality manager during internal and external audit.

- Conduct QC test for every batch of raw material, in-process and finished product.

- Execute the technical transfer and validation protocol for QC assays.

- Assist in the implementation of new assay methodologies and the associated instrumentation.

- Proper issuance and filing of documents in accordance with GxP documents.

- Perform equipment monitoring and basic housekeeping.

- Perform routine clean room sanitization task to maintain the cleanroom ISO standards.

- Identify and facilitate continuous improvements.

- Maintains inventory and submit purchase requests as needed.

- Any other tasks / projects assigned by supervisor.

Job Requirements:

- Degree in biomedical science/biotechnology or related discipline.

- 1 - 3 years working experience in QA/QC role or relevant work experience in similar manufacturing industry or cleanroom environment.

- Proven experience in cGMP, FDA regulations and ICH Guidelines regarding the manufacture of biological products.

- Good knowledge in quality assurance tools, concepts, and methodologies.

- Experience in writing and/or review of GxP documents to ensure good documentation, data integrity, GxP and regulatory requirements are met.

- Experience in cell/gene therapy is preferred.

- Expertise in cell culture, flow cytometry and molecular biology.