Quality Analyst (Pharmacist)_TAPI

Recruiting Company

Teva API Japan LTD

Who are we?

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds.

Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List.

Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

The opportunity

Teva, world leader with over 40.000 employees, in the field of equivalent medicines, with a differentiated business that also includes specialist medicines, over-the-counter drugs and the production and marketing of APIs (active pharmaceutical ingredients), is present in Japan for long time with a API commercial branch and dosage form manufacturing.

Our mission is simple: improve the wellbeing of our patients. We care about them and about our colleagues, creating a respectful, diverse and inclusive working environment, committing ourselves to maintaining high standards of quality, compliance and safety, always respecting our values. The incumbent will have an opportunity to work in highly professional and learning environment with endless opportunities to grow within organization.

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.

KEY RESPONSIBILITIES

• To work as Pharmacist and manage quality activities at TAPI Japan (QMS Management) Including Change control, Deviation, CAPA, etc.
• 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
• Handling regulatory and customer inspection at warehouse
• Developing and executing CAPA plan for improvement opportunities
• 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
• Having good knowledge of Japan Quality Regulation and Japan GMP

【Expected】

• Having exposure of coordination with regulatory agency. As this work needs communication with agency and able to convince them as needed
• Having experience of handling regulatory audits, as this is routine activity
• Good communication skill and fluent in English communication
• Person should have the knowledge of Commercial requirements for exp. Sales / release / dispatch
• Business Travel, as and when required

Enjoy a more rewarding choice

Work Place: 7F, 5-1-5, Toranomon, Minato-ku,Tokyo 105-0001 Japan  (Kamiya-cho)

Salary/Annual Income: Determined according to company regulations
Performance bonus: once a year (paid next year)
Trial period: Yes (3 months)
Working hours: 9:00-17:45 (60 minute break; flex system available)
Details of treatment will be announced at the time of interview.

Make a difference with Teva Pharmaceuticals

Apply Online now!

Report to

Associate Director (Teva AMSO Quality Compliance)

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Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.