QC Data Reviewer

Responsibilities:

• 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:

• Bachelor's Degree or above in Pharmacy or Chemistry related major
• 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 3 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.