QC Data Reviewer

WuXi AppTec Singapore Pte. Ltd.; Singapore; Sur place; SGD 60 000 - 90 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

GMP compliance

Lab data review

Analytical method writing

English/Chinese communication

Formation

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

Outils

Waters Empower 3

Agilent CDS 2

Description du poste

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.