GMP Data Integrity Reviewer

WuXi AppTec Singapore Pte. Ltd.; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

WuXi AppTec Singapore Pte. Ltd. is seeking a GMP‑minded Lab Reviewer to audit analytical records, update procedures, and support regulatory alignment. You will operate chromatography software, review methods, and ensure data integrity with cross‑functional teams.

The role requires a chemistry or pharmacy background, proficiency in English and Chinese, and at least 3 years of lab data review experience, with a focus on GMP compliance and regulatory documents across multiple markets.

Qualifications

• Bachelor's degree or above in Pharmacy or Chemistry related major.
• Familiar with GMP regulations.
• Proficient in English and Chinese, fluent in spoken and written communication for diverse stakeholders.
• At least 3 years’ lab-related work; GMP data review experience preferred.
• Familiar with analytical operation specifications and data integrity guidance.
• Knowledge of data integrity for analytical software.

Responsibilities

• Capable of operating chromatographic software such as Waters Empower 3 and Agilent CDS 2.
• Familiar with Analytical Lab procedures and able to identify errors in analytical records.
• Review analysis methods, testing plans, calculations, and data integrity per SOPs.
• Timely report errors identified in reviews to ensure GMP compliance.
• Follow Lab events, OOX, and Deviation processes; participate in investigations as needed.
• Assist in updating procedures and ensure proper execution.
• Support Lab management to maintain good Lab conditions and 5S compliance; ensure safety of staff.
• Study regulatory documents (BP, USP, JP, EP) and reference them when updating internal procedures.
• Assist supervisor in audits with customers and government; rectify issues to uphold GMP compliance.
• Handle other tasks as assigned and assist department leaders in building a high-efficiency team.

Skills

GMP compliance

Lab data review

Analytical method writing

English/Chinese communication

Education

Bachelor's degree or above in Pharmacy or Chemistry related major

Tools

Waters Empower 3

Agilent CDS 2

Job description

WuXi AppTec Singapore Pte. Ltd. is seeking a GMP‑minded Lab Reviewer to audit analytical records, update procedures, and support regulatory alignment. You will operate chromatography software, review methods, and ensure data integrity with cross‑functional teams.

The role requires a chemistry or pharmacy background, proficiency in English and Chinese, and at least 3 years of lab data review experience, with a focus on GMP compliance and regulatory documents across multiple markets.