Perform release test, environment monitoring, methodology study as per procedure.
Perform Lab tests, calculations and necessary reviewing of Lab records.
Timely report lab issues of any case and ensure GMP compliance.
Timely document the observations in case of Lab event, OOX and deviations and involve in the investigations if necessary.
Involve the update the lab procedure, ensure execution.
Use instruments as per Lab procedure, maintain Lab equipment as in good order, conduct preliminary trouble shooting, timely report instrument issues.
Proactively study regulatory documents from various countries, such as BP, USP, JP, and EP, and refer to these documents when updating internal procedures
Participate in customer audits and government inspections, promptly address identified issues, and ensure GMP compliance
Timely track work progress, strengthen communicati...