メディカル・バイオ - メディカルGQP・GMP・品質保証・品質管理

Local device stewardship is expected to be the master of devices and accountable for the related information/communication demonstrating following duties locally to meet business needs in Asia-Pacific region.

・Understand technical principle and mechanism of devices behind scientific principles.
・Transform technical information into non-technical communication in the appropriate form (e.g. verbal, written sentence, picture, drawing) that fit to needs.
・Provide technical support for going business timely.
・Ensure appropriate consistency and accuracy between technical information and non-technical communication across materials, media, channel and parties.
・Maintain appropriate consistency and accuracy with global information/direction owned by global product stewardship and/or process/engineering expert across devices, across materials/reports.
・Obtain necessary technical information timely from global product stewardship and/or related process/engineering expert.
・Develop local training material for device and provide training including call center and third party, being qualified for trainer training for the device trainings.
・Review materials/reports for device related contents.
・Educate individuals in Quality Assurance organization to help them better perform in responsible area.
・Be familiar with global and local key regulatory requirements, standards, those relate to devices.
・Collaborate for device related activities with associated functions understanding the requirement and the system.
・Demonstrate to be trusted and appreciated from customers.
・Evaluate the completed complaint investigation and identify an appropriate customer response.

■休日：完全週休二日制, 祝日, 夏季休暇, 年末年始

下記は担当・担当課長の必須条件です。

＜Education/Skill Requirements＞
・+ Two years of Quality Assurance, Engineer experience in Pharmaceutical & Medical device Industry (e.g. injector, Gastroscope (Becton, Nipro, Termo, Canon, etc)
・Strong verbal and written communication skills in Japanese(Native) and English (Preferable: TOEIC score = 750 or above)
・A bachelor’s degree in Science related field (e.g., pharmacy, chemistry, biology or engineering)

＜Minimum Requirements＞
・Have basic engineering and process knowledge or interest
・Strong Lilly product knowledge relating to how products work medicinally and functionally
・Solid collaboration and interpersonal skills
・Self-management/motivated with an ability to work independently within a structured process
・Excellent teamwork with an ability to multi-task
・Strong critical thinking/problem solving skills with an ability to apply rationale
・Ability to mentor/train others - share learning

■職種未経験者：不可