Malaysians are welcome to apply
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.
- Self-initiated, able to work independently and in a team.
- Ability to communicate at all levels.
Career Level
- Junior – Mid level Executive
