Pharmaceutical Quality Professional (Pharmacist) - TAPI
Tokyo, Japan, 105-0001
Recruiting Company
TAPI Japan LTD
Who we are
At TAPI, we’re not just a company—we’re a community committed to advancing health from the core. As the world’s leading supplier of active pharmaceutical ingredients (APIs), we partner with 80% of the top 50 global pharmaceutical companies. With a legacy spanning over 80 years and a portfolio of more than 350 products, as well as custom CDMO services, we’re shaping the future of health worldwide.
Our strength lies in our people—a team of over 4,200 professionals across 13 state-of-the-art facilities in Italy, Hungary, the Czech Republic, Croatia, Israel, Mexico, and India. Together, we innovate, solve problems, and deliver excellence. Join us and be part of a mission that transforms lives.
The opportunity
TAPI is the leading international supplier of active pharmaceutical ingredients (APIs). With the industry's broadest portfolio including over 350 API products. We are the go-to global supplier for APIs, supporting 80% of top 50 global pharmaceutical companies. We are proud of our reliable history in the generic API industry dating back over 80 years, and the fact we are considered to be one of the most trusted API suppliers, these enable TAPI to lead the industry, based on our experience, expertise, technologies, and exceptional customer service.
Our employees are at the core of our success. Our Headquartered is in Israel, TAPI employs more than 4,000 professionals at 14 sites worldwide. Our state-of-the-art production facilities are located in Italy, Hungary, the Czech Republic, Croatia, Israel, Mexico and India. Our significant ongoing investment in R&D generates a steady flow of APIs, enabling timely introduction of new products to market.
The position includes the exposure to work with different overseas manufacturing sites located in different part of the globe. Regular interaction with global leaders, best platform to use your quality and regulatory knowledge, around pharmaceutical requirements.
How you’ll spend your day
Oversight of the activities in TAPI 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 TAPI Japan Office. Guarantee the respect of applicable requirements specifically for Japan Markets.
KEY RESPONSIBILITIES
- To work as Pharmacist and manage quality activities at TAPI Japan (QMS Management) Including Change Control, Deviation, CAPA, Complaints, Temperature Excursions and so on.
- Supervise all inbound and outbound API shipments in TAPI-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 TAPI JP activities.
- Coordination with regulatory agency for regulatory related activity.
- And any other assignment related to quality aspects.
Your experience and qualifications
【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.
Make a difference with Teva Pharmaceuticals
Please submit your CV and a Cover Letter.
Please note that only shortlisted candidates will be contacted.
Reports To
Associate Director, TAPI Distribution & Commercial Quality
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