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 communication with internal and external clients, and establish stable and good relationships
Perform any other ad hoc duties as required by the Department
Qualifications:
Bachelor's degree or above in Pharmacy or microbiology related major
Good understanding pharmaceutical production, microbiology, testing, and quality management; familiar with GMP regulations.
Preferred to be professional Mandarin and English reading and writing ability, good communication skills in Mandarin and English to liaise with internal and external stakeholders in China and overseas.
Good computer skills.
1 to 3 years of work experience,
Willing to undertake minimally 3 months training in China
