QC/QA Officer

2 months ago


Singapore STEMIGEN THERAPEUTICS PTE. LTD. Full time
Roles & Responsibilities

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


Tell employers what skills you have

GxP
External Audit
FDA
Technical Assistance
Housekeeping
ISO
Protocol
Microsoft Word
Instrumentation
Manufacturing
Electrical Engineering
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