※Applicants must have permission to work in Japan and required fluent ~ native level Japanese.
[Salary] 8〜12 million JPY ※Experiences and skills will be considered
◆Resolution of Product Quality and Compliance Issues
- Deviation Management (in conjunction with Global Supply Quality Operations) Investigates, together with CMO and Logistics, deviations from Product Quality and Compliance requirements that occur within the responsibility of company and agrees and tracks CAPA. Local investigations may correspond to product damage, artwork and labeling errors, counterfeits, temperature excursions during transport or issues with CMO or logistics service providers etc.
- Prepare and implement GDP operation system in compliance with J- GDP requirements and global requirements.
- Ensures timely implementation of all applicable Product Quality SOPs\
◆Assure proper management for products
- Responsible for the local release of products under the distribution license, in compliance with the applicable local regulations and local procedures, prior to distribution/sale within Japan.
- Assure and creation of standard for Storage (Temp.), Display (GS1, Lot, Exp.) and Packaging
- Distribution matter （Temp., Storage condition, Pallet, EHS etc.）
- Manage Version for PI
◆Support for contract (include revise) with Japan CMO
◆Inspections and Internal Audit
- Supports the Responsible Person (RP) in the preparation and coordination of GMP / GQP / GDP Regulatory Agency inspections.
◆Operation of implementation related to GMP / GQP / GDP
◆Oversight of local Relabeling and Repackaging Operations
◆Other related activities Quality and Production management
- At least 5-year experience of quality related activities and production/manufacturing control experience at a pharmaceutical company in Japan
- Relevant educational background in Science or Engineering or Quality etc.
- Deep understanding and knowledge of technical matters and regulation in quality and local production of ethical drug
- Native level Japanese communication skill both of verbal/written. Business level English skills in reading/writing, plus commitment to improve verbal communication skill in English
- Strong negotiation and effective communication skills with internal/external stakeholders
- Being able to drive projects/tasks with minimum supervision independently
- Being able to collaborate effectively in a cross-function team
Please click "apply" if you are interested in the job.
We will review your profile and contact you within five business days should we find that you satisfy the requirements of the hiring company.
Further details about the company and position will be notified at a later date.
Seniority Level: Mid-Senior level
Job Function: Quality Assurance