Instrument Engineer

2 weeks ago

Singapore STA PHARMACEUTICAL SINGAPORE PTE. LTD. Full time
Roles & Responsibilities

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.

Working Location:

  • Tuas, Singapore
Tell employers what skills you have

Budgets
USP
Troubleshooting
CAPA
Construction
Quality Management
GMP
Electrical
Chemistry
Project Management
Audits
Instrumentation
Laboratory
Commissioning
Analytical Instruments

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