QC, Special Test Analyst (Fresh Graduate)

Responsibilities:

• Perform the tests involving with special test instruments (GCMS/LCMS/LCMSMS/IC/PSD/ICPMS).
• Perform Lab tests, calculations and necessary reviewing of Lab records.
• Timely report lab issues of any case and ensure GMP compliance.
• Involved in the procedure update and ensure execution.
• Use instruments as per Lab procedure, maintain Lab equipment as in good order, conduct preliminary trouble shooting, timely report instrument issues.
• Assist necessary Lab investigation, keep good Lab environment, meet 5S and EHS requirements, ensure Lab safety and the safety of Lab staff.
• Follow the requirements of Lab events, OOX, Deviation and involve the investigation if necessary.
• 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:

• Diploma or above in Pharmacy or Chemistry related major
• Understand pharmaceutical production, testing, and quality management; familiar with GMP regulations
• Prefer to be proficient in English and Chinese, fluent in spoken English and Chinese to liaise with internal and external stakeholders in China and overseas
• Good computer skills.
• Proficient in analytical testing and quality management, familiar with the structure and working principles of analytical instruments
• Familiar with industry laws and regulations regarding technical specifications for analytical operation
• Familiar with industry requirements for data integrity of analytical software; candidates with experience in computerized systems validation will be given priority
• Strong ability to handle on-site issues, with good coordination, communication, and execution skills;
• Detail-oriented, proactive, and able to work under pressure
• Ability to determine problems, gather information, understand facts, and draw correct and effective conclusions through scientific reasoning.
• Project management and tracking skills.