Capable of operating chromatographic software such as Waters Empower 3,Agilent CDS 2.
Familiar with Analytical Lab procedures, capable of identifying various errors in the analytical records.
Conduct the review of analysis methods, testing plans, experimental record calculations and data integrity strictly in accordance with relevant SOPs.
Timely report the identified errors in reviewing to ensure GMP compliance.
Follow the requirements of Lab events, OOX, Deviation and involve the investigation if necessary.
Involve in the procedure update and ensure procedure execution.
Assist the Lab management, ensure good Lab condition, ensure 5S compliance, sure Lab safety and the safety of Lab staff.
Proactively study regulatory documents from various countries, such as BP, USP, JP, and EP, and refer to these documents when updating internal procedures.
Assist the supervisor in participating in customer and government audits, promptly complete the rectification of identified items, and ensure GMP compliance.
Responsible for other tasks temporarily assigned.
Assist department leaders in building a high-efficiency team.
Requirements:
Pharmacy or Chemistry related major, bachelor's degree or above.
Understand pharmaceutical production, testing, and quality management; familiar with GMP regulations.
Proficient in English and Chinese, fluent in spoken English and Chinese to liaise with internal and external stakeholders based on China or overseas.
At least 3 years experience of Lab related work. More than one year of GMP data review or related working experience.
Familiar with industry laws and regulations regarding technical specifications for analytical operation and the writing requirements for analytical methods within the industry.
Familiar with industry requirements for data integrity of analytical software
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.
