Job Description

Major responsibilities

  • Facility & Utilities Qualification (URS/DQ/IQ/OQ/PQ): Coordinate qualification of cleanrooms (ISO classes), HVAC, process gases, and PW/PS systems; ensure environmental monitoring programs are defined and validated.
  • Equipment Qualification: Plan and witness the IQ/OQ/PQ for critical assets (biosafety cabinets, incubators, centrifuges, isolator, cryogenic freezers, liquid nitrogen storage, autoclave, QC instruments), including communication and coordination with equipment suppliers or third-party validation service providers.
  • Aseptic process stimulation: Organizing or coordinating aseptic process simulation.
  • Third-party Validation Service: Responsible for reviewing validation or qualification protocols provided by suppliers, assisting and supervising the implementation of supplier protocols, and promptly reporting any problems discovered during implementation;
  • Documentation & Compliance: Draft and maintain validation mast...

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