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| Occupation | Compliance & Assurance Department ▶job description |
|---|---|
| Department | Iwate Quality Assurance Group |
| Joined the company | Joined 2019 |
| University Department | Sciences Department of Agriculture Applied Biochemistry Course |
Carrier
| April, 2019 | Assigned to the Compliance & Assurance Department |
|---|---|
| October, 2019 | Transferred to Iwate Quality Assurance Group |
Daily schedule
Interview
Tell us why you decided to join SEKISUI MEDICAL.
In graduate school, I studied the effects of food ingredients on the prevention and alleviation of lifestyle-related diseases using cultured cells. As a result, I became interested in disease prevention and treatment, and after graduation, I wanted to work in a field related to people's health. I decided to join Sekisui Medical because I thought I could achieve this goal at the company, which is engaged in a wide range of businesses from disease prevention to treatment. In addition, through interviews and interactions with employees, I learned that the company has an excellent education and training system, and that even young employees have the chance to be entrusted with important tasks, so I was attracted to the environment that would lead to my personal growth.
Tell us about your current job and what makes it interesting and challenging.
The Iwate Quality Assurance Group is responsible for creating a framework for manufacturing and quality control of APIs in compliance with domestic and international pharmaceutical laws and regulations, and for promoting and confirming the proper operation of this framework to ensure product quality. Currently, I am mainly involved in regulatory affairs with overseas authorities and change management. Change management involves evaluating the impact of changes in manufacturing methods, etc. on quality and scientifically verifying the appropriateness of the changes. I am specifically responsible for checking the resulting documents. These tasks are essential for quality enhancement. If quality is effected due to inadequate checks, the health of patients and the trust in the company could be damaged. As we are required to accurately understand the situation and determine the most appropriate response, our responsibilities are heavy and our worries are endless. However, as I learn and gain more experience every day, I feel that my perspective is broadening and I am growing. I believe that this growth will lead to the protection of product quality and the health of patients, and this motivates me.
What are your future goals and career plans?.
As the overseas development of our products expands, compliance with future pharmaceutical laws and regulations will increasingly require strict management to meet international standards. My current goal is to become a person who can contribute to the global expansion of the pharmaceutical business by promoting the strengthening of the quality assurance systems to meet these requirements. To achieve this goal, I am studying and updating my knowledge on a daily basis so that I can become familiar with the changing pharmaceutical laws and regulations of each country and determine and implement measures to close the gap between the requirements and the current situation. In addition, as global inspections and audits increase, we expect to have more opportunities to communicate with overseas customers and authorities. To be able to play an active role on the front lines in such cases, we are working to improve the language skills of our employees by utilizing our in-house training systems. At SEKISUI MEDICAL, we have an environment that supports this kind of willingness to learn, and I believe that actively engaging in this environment will lead to career growth.
What are the points you feel proud of your office?
I eat lunch at the cafeteria in the factory. I always order the daily set meal, which is hearty and delicious, and I am proud of the fact that it is only 180 yen.
How do you spend your day off?
On my days off, I often take a ground sheet and lunch box and drive to a scenic park for a leisurely meal and a walk. I love the rich nature of Iwate, and it is a very nice change of pace.