Scientist, QC Project Management

Responsibilities:

• Perform method verification, validation and transfer as per procedure.
• Perform Lab tests, calculations and necessary reviewing of Lab records.
• Timely report the identified errors in analytical records to ensure GMP compliance.
• Initiate the related change controls and ensure execution of actions.
• Follow manufacturing progress, ensure availability of reference standards, chromatographic columns and all the test necessaries before the start of manufacturing.
• Involve in the procedure update and ensure procedure execution.
• Communicate with TO and QC project management team. Ensure smoothness of the tests.
• Involve in the Lab management, maintain good working environment, ensure 5S and EHS requirements, ensure Lab safety and the safety of Lab staff.
• Proactively study regulatory documents from various countries, such as BP, USP, JP, and EP, and refer to these documents w...