Scientist, IPC Analyst

WuXi AppTec; Singapore; On-site; SGD 45,000 - 71,000; Full time

Job summary

WuXi AppTec in Singapore seeks a Lab Analyst to perform IPC tests, conduct routine lab analyses, review records, and report issues to ensure GMP compliance.

You will document observations for lab events, OOX and deviations, update procedures, and maintain instrument readiness. Strong data integrity awareness and ability to work shifts, including training in China, are required.

Qualifications

• Diploma or degree in pharmacy or chemistry related major; fresh graduates welcome.
• Understand pharmaceutical production, testing, and quality management; familiar with GMP regulations.
• Familiar with data integrity requirements for analytical software; CVs mentioning computerized systems validation are a plus.
• Strong coordination, communication, and execution skills; able to work under pressure.
• Willing to work shift hours and undertake min 3 months training in China.

Responsibilities

• Perform IPC tests as per analytical procedure.
• Perform Lab tests and calculations and necessary reviewing of Lab records.
• Timely report lab issues of any case and ensure GMP compliance.
• Timely document the observations in case of Lab event, OOX and deviations and involve in the investigations if necessary.
• Involve in the Lab management, maintain good working environment, ensure 5S and EHS requirements, ensure Lab safety and the safety of Lab staff.
• Communicate with TO and QC project management team. Ensure smoothness of the tests.
• 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.
• Responsible for other tasks temporarily assigned.

Skills

GMP knowledge

Data integrity

Analytical testing

Regulatory awareness

Communication

Education

Diploma or degree in Pharmacy or Chemistry

Job description

• Perform IPC tests as per analytical procedure.
• Perform Lab tests and calculations and necessary reviewing of Lab records.
• Timely report lab issues of any case and ensure GMP compliance.
• Timely document the observations in case of Lab event, OOX and deviations and involve in the investigations if necessary.
• Involve the update the lab procedure, ensure execution.
• Use instruments as per Lab procedure, maintain Lab equipment as in good order, conduct preliminary trouble shooting, timely report instrument issues.
• Involve in the Lab management, maintain good working environment, ensure 5S and EHS requirements, ensure Lab safety and the safety of Lab staff.
• Communicate with TO and QC project management team. Ensure smoothness of the tests.
• 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.
• Responsible for other tasks temporarily assigned.

Requirements:

• Diploma or Degree in Pharmacy or Chemistry related major. Fresh graduates are welcome to apply
• Understand pharmaceutical production, testing, and quality management; familiar with GMP regulations.
• Familiar with industry requirements for data integrity of analytical software; candidates with experience in computerized systems 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.
• Willing to work shift hours and undertake min 3 months training in China