Analytical test method verification (QA)

• Verification of compendium (USP, EP, JP, etc.) test methods

• Review and study of guidance and regulations on product approval and registration overseas, and management of registration and status for each targeted country

• Support for transfer of analysis technology for test methods and preparation of validation documents in English

• Support for environment monitoring trend report preparation, disinfectant effectiveness evaluation, etc.

• Ensure the implementation and compliance with Good Manufacturing Practices

• Write, review, and approve validation master plans, validation plans, SOP’s and other validation documentation

• Prepare validation plan/protocols for production processes such as process validation, cleaning validation, filtration validation, etc

• Prepared and evaluate SOP, Work Instruction and Forms in the company as well as determine and supervise the implementation of a record keeping system of all activities