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.
Beware of fraud agents! do not pay money to get a job
MNCJobz.com will not be responsible for any payment made to a third-party. All Terms of Use are applicable.