Instrument Engineer
2 days ago
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
- Assist department leaders in building a high-efficiency team.
- Perform any other ad hoc duties and responsibilities assigned by the Department Lead.
Requirements:
- 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 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 will be given priority
- 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 required an on-the job training in China for approximately 3 to 6 months.
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