Labeling Specialist, Quality JPN

Founded in 2014, Mérieux University is the Group's university.

A privileged space for innovation and collaboration, marked by the Institute's humanist and entrepreneurial culture, the University designs and conducts global training programs with high added value for all the Group's entities and customers. It also offers individual and group coaching.

As an educational reference, Mérieux University strives to understand the changes in the businesses and environment of the Group's companies, to anticipate the associated skills and to support the development of employees, both in terms of technical and behavioral aspects.

We are a team of 24 people based in France or in the United State (North Carolina), passionate and committed, with professional teaching skills and expertise in complementary areas of business.

We are committed to creating an optimal work environment that fosters teamwork, emphasizes training and offers international career development opportunities.

The headquarter of Mérieux University is located to the west of Lyon (France) in “le Domaine de Montcelard”, and 4 Regional Hubs are dedicated to our international sessions (China, USA, Shanghai, France).

1            Primary Purpose and Overall Objective of the Job:

Confirm final product testing results as defined to ensure IVD product meets the approved, certified or registered acceptance criteria prior to the product’s release for commercial sale.Ensure that IVD products are released with Japanese labels required by PMD Act.

2            Main Accountabilities:

•             Confirm that all IVD products meet the approved, certified or registered product performance spec, and have regal Japanese labels.

•             Assures that proper documentation of;

          IVD Product Standard “製品標準書” including Packaging Instruction $ Inspection Record “包装指図書・検査記録”

          Release judgment of each IVD lot

          Visual inspection results

•             Support customer complaint to prevent recurrence of the issue, such as damaged product, foreign matter contamination, etc.

•             Provides support to product and process improvement projects.

3            Typical Studies-Experience, Skills and Qualifications:

3.1 Studies-Experience(Preferable)

-            More than 3years of industry experience or equivalent experience.

-            QMS laboratory experience with a working knowledge of Microbiology/Biochemistry/Immunology test methods.

3.2 Skills and Qualifications:

#1 QMS skill: 薬機法/QMS省令/ Global手順の理解と実践,Local手順書の作成 #2 Quality Tools / Training ability: ISO9001/品質管理Tool等の理解と実践、トレーニングの実施 #3: Product Knowledge #4: Job Management skill #5: Interpersonal Skill #6: English Communication #7 Audit skill