募集要項
- 募集背景
- A global regulatory solutions company is seeking a QA Manager of DMAH/MAH. The selected candidate will oversee GQP activities and ensure full compliance with Japan's regulatory requirements.
- 仕事内容
-
A global regulatory solutions company is seeking a QA Manager of DMAH/MAH.Responsibilities:
* Manage GQP tasks including manufacturing record review and deviation management
* Oversee change controls, CAPA, and quality-related documentation
* Review QA submission documents and assess change control impact
* Lead commercial batch release processes and ensure QMS compliance
* Maintain and update SOPs, conduct vendor audits, and handle market complaints
* Ensure adherence to Japanese pharmaceutical regulations and quality practices
* Serve as a QA Manager, collaborating closely with the RA and CMC teams to provide end-to-end client support up to the delivery of regenerative medicines
Requirements:
* Bachelor's degree or above in biological sciences (medicine, pharmacy, science, agriculture, etc.)
* 2-3 years of experience in QA
* Experience in conducting the GMP audit for manufacturing site
* Prior experience in reviewing all QA submission documents, change control assessment, batch release of commercial products, QMS, SOPs, vendor audit market complaints, etc.
* Proven experience in supporting GMP inspections by PMDA or authority in Japan (other countries are ideal)
* Background in preparing pharmaceutical documents to be submitted to Japanese regulatory authorities (PMDA and MHLW)
* Prior background in GMP audit by PMDA is a plus
* Knowledge of the regulations related to the application and approval of ethical pharmaceuticals, OTC, or regenerative medical products
* Native level Japanese; proficient in English
- 応募資格
-
- 必須
-
2-3 years of experience in QA
- 雇用形態
- Permanent
- 勤務地
- Kanagawa
- 年収・給与
- JPY5,000,000.00 - JPY7,000,000.00 per annum
