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To be responsible for the microbiological test of raw materials, intermediate, finished products and inner package material. To perform the test for registration, method validation and the product stability tests. Be responsible for sampling and monitoring for the water system and compress gas system in the site. Be responsible for calibration of related instrument in microbiological laboratory. Be responsible for initial and maintenances, the related Standard Operating Procedure, test method. To instruct the new staff.
Job Responsibility:
Perform microbiological related test of raw materials, intermediate, finished products and inner package material
Be responsible for the original analysis result
Be responsible for the preparation of reagents, media, rinse fluid and so on
Be responsible for the validity of reagents, media and rinse fluid
Responsible for the management of laboratory strains, passaging and storing strains according to requirements
Perform method validation and product stability study
Be responsible for the usage, calibration, cleaning and maintenance of the instruments
Perform the sampling and monitoring of the water system,pure steam and compress gas system
Be responsible for initial and maintenances the related Standard Operating Procedure, test method and assist in preparation of product quality and chemical test technical document
Be responsible for organizing the preparation of technical documents related to quality or chemical test and the management and filing of those documents
Perform the test for registration and complaint investigation
Train the new staff
Stay in touch with Pfizer's technical team, participate in relevant technical forums, participate in relevant microbiology assessments
Carry out other works assigned by Quality Operation Manager or Quality Control Supervisor
Comply with Environment \Health\ Safety policy and regulation, and complete the Environment \Health\ Safety related work.
Requirements:
College degree or above, major in pharmaceutical / bioengineering/biotechnology or other biological related work experience
Master Pfizer Quality Standards, Good Manufacturing Practices and related regulations
Have good English and computer application ability
To be cooperative and have sense of responsibility