QC Project Lead — Analytical Lab & GMP Compliance

WuXi AppTec Singapore Pte. Ltd.; Singapore; On-site; SGD 47,000 - 73,000; Full time

Job summary

WuXi AppTec Singapore Pte. Ltd. is seeking a QA/Analytical Lab Specialist with a strong background in GMP, analytics, and project coordination.

The role requires a Bachelor's degree in Pharmacy or Chemistry, fluent English and Chinese, and at least 2 years of lab experience with 1 year in project management. You will verify methods, perform lab testing and ensure compliance with regulatory standards. Responsibilities include method verification/validation, transfer, change controls, data

Qualifications

• Bachelor's degree and above in Pharmacy or Chemistry related major.
• Familiar with GMP regulations.
• Proficient in computer applications.
• Minimum 2 years’ Lab experience and 1 year of project management experience.
• Experience with analytical data integrity and method validation preferred.
• Strong coordination and execution skills; able to work under pressure.
• Ability to analyze problems and draw correct conclusions.

Responsibilities

• Perform method verification, validation and transfer as per procedure.
• Perform Lab tests, calculations and necessary reviewing of Lab records.
• Timely report the identified errors in analytical records to ensure GMP compliance.
• Initiate related change controls and ensure execution of actions.
• Follow manufacturing progress, ensure availability of reference standards and testing materials.
• Involve in procedure updates and ensure procedure execution.
• Communicate with TO and QC project management team to ensure smooth tests.
• Involve in Lab management, maintain good working environment, 5S and EHS requirements, ensure Lab safety of staff.
• Proactively study regulatory documents from BP, USP, JP, and EP and update internal procedures.
• Participate in customer audits and government inspections, address issues and ensure GMP compliance.
• Timely track work progress and maintain strong relationships with internal and external clients.

Skills

GMP knowledge

Lab management

Communication (English/Chinese)

Data integrity

Problem solving

Project management

Education

Bachelor's degree in Pharmacy or Chemistry

Job description

WuXi AppTec Singapore Pte. Ltd. is seeking a QA/Analytical Lab Specialist with a strong background in GMP, analytics, and project coordination.

The role requires a Bachelor's degree in Pharmacy or Chemistry, fluent English and Chinese, and at least 2 years of lab experience with 1 year in project management. You will verify methods, perform lab testing and ensure compliance with regulatory standards. Responsibilities include method verification/validation, transfer, change controls, data