Quality Control Data Reviewer

Role overview

WuXi AppTec is looking for a Quality Control Data Reviewer to support laboratory quality operations in Tuas, Singapore. The role focuses on checking analytical records, confirming data integrity, and helping maintain GMP-compliant lab practices.

Key responsibilities

• Use chromatographic systems such as Waters Empower 3 and Agilent CDS 2 to support review activities.
• Review analytical methods, test plans, experimental records, calculations, and data integrity in line with the applicable SOPs.
• Identify mistakes or gaps in analytical documentation and report them promptly to support GMP compliance.
• Handle lab events, OOX cases, and deviations, and participate in investigations when required.
• Contribute to procedure revisions and help ensure updated procedures are properly followed.
• Support lab administration by maintaining a clean, well-controlled, safe, and 5S-compliant working environment.
• Apply knowledge of regulatory references such as BP, USP, JP, and EP when updating internal procedures.
• Support customer and government audit activities, complete corrective actions on time, and help keep the site GMP-ready.
• Take on other duties assigned from time to time.
• Assist department leadership in developing an efficient and high-performing team.

Requirements

• A bachelor's degree or higher in Pharmacy, Chemistry, or a related field.
• Good understanding of pharmaceutical manufacturing, testing, and quality systems, with familiarity in GMP requirements.
• Strong command of both English and Chinese, including spoken fluency for communication with internal and external stakeholders in China and overseas.
• At least 3 years of laboratory-related experience, including more than 1 year in GMP data review or a closely related role.
• Knowledge of technical standards for analytical operations and the documentation requirements for analytical methods.
• Understanding of data integrity expectations for analytical software used in the industry.
• Ability to manage on-site issues effectively, with solid coordination, communication, and execution skills.
• Careful, proactive, and capable of working well under pressure.
• Strong analytical thinking, including the ability to identify issues, collect relevant information, interpret facts, and reach sound conclusions.

Work environment

This is a full-time, on-site position based in Tuas, West Region, Singapore.