Process&QA Control Manager/Staff (Tokyo、7m〜)

東京都 外資系企業 外資系企業
  • World-famous biopharmaceutical company.
  • Excellent opportunities of professional growth.

企業情報

Our client is multinational pharmaceutical company headquartered in the UK. As a science-led global health care company, they are pioneers in development pharmaceutical products and methods, with a special purpose to improve the quality of human life by helping people do more, feel better and live longer.

職務内容

· Ensure all coordination in Licensing Partner (LP) Pharmacovigilance audit.
· GVP/GPSP self-inspection related activities.
· As a GVP/GPSP self-inspection responsible person, propose and implement annual self-inspection plan.
· Conduct the self-inspection and then report the outcome to Safety responsible or PMS responsible in writing.
· Author and review local GVP/GPSP SOPs related to self-inspection.
· Works in close collaboration with PVQA Team in PV audit conducts in Japan.
· Communicate with Licensing partner or vendor to prepare logistics solutions.

理想の人材

· Excellent knowledge and deep understanding of GVP/GPSP regulations.
· Experience in response to the PV audit conducted by Licensing partner.
· Experience in conduct GVP/GPSP self-inspection or GCP audit.
· Experience in response to the PMDA inspection (GPSP/ GCP) , and/or TMG inspection for licensing renewal.
· Experiences in drug safety.
· Experiences in Post Marketed Surveillance activities.
· Lead experiences in preparation/ maintenance of PV Agreement.
· Experiences in CAPA implementation and tracking

· Ability to work collaborate with cross functional teams, Communication skill.
· Self-management ability (manage tasks and schedules) and eagerness to learn new things.
· Life-science bachelor/advanced degree.
· Good skill of communication (speaking and writing) in English and Japanese.

条件・待遇

· Be part of a company committed to delivering high quality results where you will be continuously looking for opportunities to learn, build skills and share learning both internally and externally.
· Attractive salary package.

コンタクト
Eduardo Takara
求人番号
4204340
電話
+813 6832 8678

求人情報

職種
勤務地
雇用形態
担当コンサルタント
Eduardo Takara
担当コンサルタントの電話番号
+813 6832 8678
求人番号
4204340
企業タイプ