Quality Specialist - Thailand

Who We Are:-

A family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. Our entrepreneurial adventure, begun over a century ago, is driven by an unrelenting commitment to improve public health worldwide.

Since 1963, we've been paving the way in the field of in vitro diagnostics and have contributed greatly to improving public health and making the world a healthier place. The solutions that our teams imagine, develop and manufacture are key to enable healthcare professionals and industry players to make confident decisions to improve patient outcome and ensure consumer safety.

It is today present in 44 countries, serves more than 160 countries with the support of a large network of distributors, and supported by more than 13,000 employees worldwide.

Primary Purpose and Overall Objective of the Job:

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

Main Accountabilities:

• This position serves as the QMR Quality Management Representative for BioMerieux Thailand subsidiary.
• 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, publishing, 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/Educational 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.