Requisition ID: 1905768197W
- Ensure that a Quality system and Standard Operating Procedures are in
place for all J&J consumer product related activities in Japan in
supporting county BQ head
- Ensure that all products are released
to the market in accordance with the registered specifications and with local
regulations and internal J&J guidelines.
- Manages the nonconformance product
handling, monitoring the implementation of corrective action, managing
quality information overall management including communicating, processing
and archiving, and analyzing the various problems, issuing investigation
reports and determining corrective actions, monitoring and measuring the
effectiveness of the corrective actions.
- Review and evaluate quality
information such as NPD/NPI, Deviations or process changes that would impact
on product quality.
- Manage GxP suppliers including the
process of Selection, Qualification, QRA, Audit, Approved Supplier Listing
- Lead and manage the operation QA
staff in Tokyo and Kuki Distribution center. Frequency for KUKI DC visit in
general: Once a week
- Evaluates performance and provides
opportunities for growth for staffs.
- Support Japan BQ Head as delegate if
required (Back up person for the product release).
- Establish a good working relationship
with the other counterpart and to make synergy.
- Degree in science or pharmacy and/or +10 years of experience in quality
management activities in healthcare industries (Pharmaceuticals, Quasi-Drugs,
Cosmetics, Medical Devices, or General Commodities)
- Experience in cross-functional
- Verbal and written communication skill in
Japanese and English
- Computer skill with MS-Office applications (Word,
Excel, and PowerPoint)
- Sufficient knowledge of global/local regulations
such as J-PMD Act, cGMP, GQP, GDP etc.
- Demonstrated experience coaching and developing
- Strategic/ logical thinker
and strong analytical skills
- Analyze problems, detect root cause and solve the
Bachelor of Science (e.g. in
Pharmaceutical Sciences, Chemical, Biology, Chemical Engineering and so on)
or above, or equivalent qualification
・Can-do attitude and
solution oriented person
・Reliable and ethical
・Energetic and positive
attitude towards changes
Experience in QC or RA in
addition to quality function
Project management and people management
Johnson & Johnson K.K. (8235)Job Function
Quality AssuranceRequisition ID