Perform Lab tests and 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.
Involve in the Lab management, maintain good working environment, ensure 5S and EHS requirements, ensure Lab safety and the safety of Lab staff.
Communicate with TO and QC project management team. Ensure smoothness of the tests.
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.
Responsible for other tasks temporarily assigned.
Team building: Assist department leaders in building a high-efficiency team.
Requirement:
Diploma and above in Pharmacy or Chemistry related major
Understand pharmaceutical production, testing, and quality management; familiar with GMP regulations
Preferred to be proficient in English and Chinese, fluent in spoken English and Chinese to communicate with China and overseas internal and external stakeholders
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.
