Quality Assurance Officer

1 week ago

Singapore STEMIGEN THERAPEUTICS PTE. LTD. Full time

**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.
- Any other tasks / projects assigned by superior and management.

**Job Requirements:
- Degree/Diploma in biomedical science/biotechnology or related discipline.
- Minimum 1 - 2 years working experience in QA 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.

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