Scientist, QC Project Management

Wuxi Apptec, Inc.; Singapore; On-site; SGD 90,000 - 130,000; Full time

Job summary

Wuxi Apptec, Inc. Singapore seeks a Lab Scientist with a pharmacy or chemistry background to perform method verification, validation and transfer, and to ensure GMP compliance of analytical records.

You will conduct lab tests, calculations and review of records, initiate change controls, ensure availability of reference standards and test necessities before manufacturing, and collaborate with TO and QC teams to keep tests running smoothly while maintaining 5S and EHS in the lab.

Qualifications

• Bachelor’s degree in Pharmacy or Chemistry with GMP understanding.
• Know-how of pharmaceutical production, testing, and quality management.
• Familiar with GMP regulations and data integrity of analytical software.
• Ability to perform method validation and on-site issue resolution.

Responsibilities

• Perform method verification, validation and transfer as per procedure.
• Perform Lab tests, calculations and necessary reviewing of Lab records.
• Timely report errors to ensure GMP compliance.
• Initiate related change controls and ensure action execution.
• Ensure availability of reference standards, columns and test necessities before manufacturing.
• Update procedures and ensure execution.
• Communicate with TO and QC project management team; ensure smooth tests.
• Involve in Lab management, maintain 5S and EHS, lab safety.
• Study regulatory documents (BP, USP, JP, EP) and refer to them when updating procedures.
• Participate in customer audits and government inspections; address issues and ensure GMP compliance.
• Track work progress and maintain relationships with clients.

Skills

Lab management

Project management

English & Chinese

Regulatory knowledge

Data integrity awareness

Education

Bachelor's degree in Pharmacy or Chemistry

Job description

• 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

Qualifications:

• Pharmacy or Chemistry related major, bachelor's degree or above.
• Understand pharmaceutical production, testing, and quality management; familiar with GMP regulations
• Proficient in English and Chinese, fluent in spoken English and Chinese
• Minimum 5 years' Lab experience and 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.