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:
Engineering, Pharmaceutical or Chemistry related major, bachelor's degree or above
Understand pharmaceutical production, testing, and quality management familiar with GMP regulations
Prior experience in instrumentation companies (e.g., Agilent, Waters, Thermo Fisher, etc.) is strongly preferred.
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 (CSV) 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.
