Quality Assurance Expert

Publication date 2025/08/29

Work Location , Expected Annual Income :

Tokyo,10.0M ～ 15.0M

About the Company :

Global API Manufacturer

Responsibilities :

How you’ll spend your day
Oversight of the activities in Japan related warehouses including Receipt and Dispatch of API shipments, Re-labelling, labelling activities and performance of annual review of the warehouse activities. Managing quality management system including all GxP activities SOP for Japan Office. Guarantee the respect of applicable requirements specifically for Japan Markets.

KEY RESPONSIBILITIES
?To work as Pharmacist and manage quality activities at Japan (QMS Management) Including Change Control, Deviation, CAPA, Complaints, Temperature Excursions and so on.

?Supervise all inbound and outbound API shipments in Japan warehouses. Fully responsible for review and batch release activity.

?Supervise the testing of samples in the external laboratory. Compile JP labels according to test results and labelling activity.

?Manage retained samples warehouse. Conducting audits to our service providers.

?Responsible for Product standard code, MRA and GQP maintenance.

?Preparation of Annual review of the warehouse activities.

?Managing the documentation for PMDA Periodic review/inspection.

?Managing the communication liaising and documentation with Japan Government agencies (TMG, MAAF, MHLW etc).

?Handling regulatory and customer inspection at warehouse.

?Developing and executing CAPA plan for improvement opportunities.

?Managing the local QMS system in order that it complies with global DP and with the JP activities.

?Coordination with regulatory agency for regulatory related activity.

?And any other assignment related to quality aspects.

Benefits :

Employment Type: Full Time Employee
Office: Tokyo, Japan
Working Style: Hybrid Working Model
Interview Steps: 2~3
Reporting line: Global Head of QA
Reporting Language: English
Budget Range: Up to 11mil annual total

Required Experience / Abilities / Skills :

【Must】
?Japan Pharmacist License.
?Pharmacy/science/Chemistry graduate/Post Graduate or equivalent.
?Business level of Japanese and English skill.
?Effective communication skills, efficient time management, team motivating manager.
?Having good knowledge of Pharmaceutical cGPM (preferably work experience in API industry), in depth understanding of Japan Quality Regulations and Japan GMP.

【Expected】
?Good knowledge of Pharmaceutical cGMP, Japanese regulations, Japan customer (MAH) expectations.
?Having exposure of coordination with Japanese government and regulatory agencies, as this work needs communication with agencies and able to efficiently liaison them as needed.
?Having experience of handling regulatory and customer as well as internal audits, as this is routine activity.
?Good communication skill and fluent in English communication.
?Excellent team player, agile to embrace the changes and guide the team with positive spirits in all business circumstances.
?Person should have the knowledge of Commercial requirements for exp. Sales / release / dispatch.
?Business Travel, as and when required.

Contact Information :

JAC International, Healthcare Team
Kent Gu
Email: k-gu@jac-international.jp

If you are interested, email us for inquiry!

JOB ID : IJB2009598