QC Lab Equipment Engineer

Responsibilities:

• Responsible for the selection/purchase, installation/commissioning, validation/calibration, maintenance, and repair of QC laboratory instruments

• Draft various procedures and technical documents related to instruments, participate in the maintenance and optimization of processes, and ensure their implementation.

• Conduct laboratory events and deviation investigations related to instrument management

• Initiate changes related to instrument management and track the timely execution of CAPA

• Assist analysts in troubleshooting during testing, and provide training on relevant skills when necessary

• Evaluate data integrity of various instrument systems and improve the department's level of data integrity

• Proactively study regulatory documents from various countries, such as CP, 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:

• Bachelor's degree or above in Engineering, Pharmaceutical 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 stakeholders from China and overseas, to support technical transfer.

• Good computer skills

• Over 3 years of work experience in the management of analytical instruments; candidates with GMP instrument management experience within the pharmaceutical industry will be given preference

• Proficient in analytical testing and quality management, familiar with the structure and working principles of analytical instruments

• Familiar with industry laws and regulations regarding technical specifications for analytical instruments

• 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.

• Project management and tracking skills.

• Ability to manage budgets and assets, controlling lab expenses.

• This role will require on-the job training in China for approximately 3 to 6 months.