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QA Specialist

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Location: Kuala Lumpur, Malaysia
Position Type: Unfixed Term
Job Function: Quality

Primary Purpose and Overall Objective of the Job:

  • To ensure quality compliance under applicable quality standards and bioMerieux corporate standards


Main Accountabilities:

  • Perform quality analysis on shipments (TTOR) after training and do the necessary release and coordination for shipment release as required
  • Manager and coordinate Internal & external audits, supplier audits, distributor audits ;
  • Perform/Support document control work including SOP drafting, revision, publish, etc.;
  • Coordinate and monitor field actions implementation and complaint handling
  • Manage and coordinate CAPA, vigilance activities;
  • To carry-out other QA activities as required for the region;
  • Main activities includes support ASEAN(including TTOR analysis, document control, TTOR, internal& external audit, management review, CAPA, vigilance, change control. etc.),


Skills/Education Requirements:

  • Good analytical, communication and interpersonal skills
  • Smooth English speaker advantageous to liaise with cross country stakeholders
  • Meticulous attention to details, able to multi-task and commit to job
  • Familiar with or trained on ISO9001:2015, GDPMD / GDPMDS Quality Management System requirements
  • Familiar in usage of Trackwise / Trackwise Digital or other relevant quality platforms.  
  • Experience in using problem-solving tools including fishbone diagrams, FMEA and 5-whys methodology are preferred
  • Degree in bioscience/life science/biomedical Engineering with minimum 3years’ relevant experience in QA environment.
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