Microbiology Testing Analyst

Key Responsibilities:

• 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