Purpose

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.

Responsibility scope

A. To perform microbiological related test of raw materials, intermediate, finished products and inner package material. And to be responsible for the original analysis result.

B. To be responsible for the preparation of reagents, media, rinse fluid and so on. And to be responsible for the validity of reagents, media and rinse fluid.

C. To be responsible for the sampling of API.

D. To perform method validation and product stability study.

E. To be responsible for the usage, calibration, cleaning and maintenance of the instruments to make the instrument run effectively.

F. To perform the sampling and monitoring of the water system and compress gas system.

G. 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. And to be responsible for organizing the preparation of technical documents related to quality or chemical test and the management and filing of those documents.

H. To perform the test for registration and complaint investigation.

I. Train the new staff.

J. Participate in keeping scientific advancement of lab.

K. To carry out other works assigned by Quality Operation Manager or Quality Control Supervisor.

L Comply with Environment \Health\ Safety policy and regulation, and complete the Environment \Health\ Safety related work.

Job requirements

Education Background/ Experience：

• College degree or above, major in pharmaceutical / bioengineering/biotechnology or other biological related work experience.

Special Knowledge：

Master Pfizer Quality Standards, Good Manufacturing Practices and related regulations.

Skills：

• Have certain English and computer application ability.
• To be cooperative and have sense of responsibility.

Have capability of communication and training.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.