QC Project Management Analyst

WuXi AppTec Singapore Pte. Ltd.; Singapore; Presencial; SGD 47.000 - 73.000; Jornada completa

Descripción de la vacante

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

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

GMP knowledge

Lab management

Communication (English/Chinese)

Data integrity

Problem solving

Project management

Educación

Bachelor's degree in Pharmacy or Chemistry

Descripción del empleo

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 the related change controls and ensure execution of actions.
• Follow manufacturing progress, ensure availability of reference standards, chromatographic columns and all the test necessaries before the start of manufacturing.
• Involve in the procedure update and ensure procedure execution.
• Communicate with TO and QC project management team. Ensure smoothness of the tests.
• Involve in the Lab management, maintain good working environment, ensure 5S and EHS requirements, ensure 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
• Participate in customer audits and government inspections, promptly address identified issues, and ensure GMP compliance
• Timely track work progress, strengthen communication with internal and external clients, and establish stable and good relationships

Qualification:

• Bachelor's degree and 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
• Good computer skills.
• Minimum 2 years’ Lab experience and one year of project management experience.
• Familiar with industry laws and regulations regarding technical specifications for analytical operation
• Familiar with industry requirements for data integrity of analytical software; candidates with experience in method validation will be given priority
• 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.
• Project management and tracking skills