QA - Pharmacist

勤務地 東京都
業界・業種 医療・製薬
契約タイプ Permanent
給料 Negotiable
参照番号 50841

QA Specialist – Tokyo

 

What We Ask

  • Japanese Pharmacist License (必須)

  • Native-level Japanese

  • English Speaking skill

What We Offer

  • International work environment

  • Continuous learning and development opportunities

  • Flat organization with short communication and decision lines

  • Flexible working style (including remote work)

Vacancy Description

You will be responsible for the following three core areas:

1. Release of Products & Role as Manager for Drug Manufacture

  • Release of all pharmaceutical product batches imported into Japan

  • Confirmation and approval of Japanese Pharmacopoeia (JP) test results in Japan

  • Respond to domestic audits from authorities and customers

2. Quality Assurance Operations

  • Request JP testing for each imported batch

  • Check Japanese labels and labeling records; issue labels for small batches

  • Manage change control in Japan and prepare change notification letters

  • Review and sign Quality Agreements with customers in Japan

3. Regulatory Affairs

  • Manage applications and changes for:

    • Pharmaceutical manufacturing licenses (office and warehouse)

    • Pharmaceutical wholesale licenses (office)