CQV Engineer - Singapur, Singapore - PM Group

    PM Group
    PM Group Singapur, Singapore

    1 month ago

    Default job background


  • Planning, Performance, and Coordination of Computer System Validation, Equipment Qualification, Temperature Controlled Objects (Freezers, Incubator etc), Clean Utilities Validation and cleaning validation in accordance with internal procedures and industry standards.
  • The qualification includes, FAT, SAT, IQ, OQ, PQ of any additional / modifications of existing manufacturing process equipment, package units (e.g. Ultrafiltration Unit, Chromatography Columns, autoclave, FIT testers), commercial off the shelves (COTS) analytical instruments, freezers,
  • Experience to creates, reviews and approve equipment qualification and analytical instruments lifecycle documentations, e.g. FAT, SAT, IQ, OQ, PQ protocols and reports, risk assessments, technical specifications.
  • Can lead investigation revolving around discrepancies identified during qualification activities.
  • Qualifications

  • Experience in coordinating the commissioning and qualification activities (including the creation, pre-execution approval, execution, post-execution review, and post-execution approval of all validation lifecycle documents)
  • Experience in leading daily validation meetings with cross functional in resolving validation issues.
  • Experience in equipment qualification including analytical instrumentation and manufacturing equipment.
  • Relevant work experience in Pharmaceutical, BioPharma or Food industries
  • Hands on validation execution experience
  • Review validation documents
  • Write validation protocols and reports
  • Able to execute activities in cGMP environment, including cleanrooms or technical areas.
  • Good command of English
  • Attention to detail