Primary Purpose and Overall Objective of the Job:
- To ensure quality compliance under applicable quality standards and bioMerieux corporate standards
- 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.),
- 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.