[CELLiST Interview] Sunyai Park, QA group leader
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작성자ajinomo 조회 369 작성일 24-07-23 15:25본문
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Introduction:
Could you please introduce yourself and share a bit about your background and interests?
I am Sunyai Park, in charge of the Quality Assurance Group at ACK. I started my career in quality control (QC) at a pharmaceutical company, then gained experience in regulatory affairs (RA) at an API (Active Pharmaceutical Ingredients) manufacturing company before moving to ACK, where I handled quality control (QC) in compliance with GMP. Currently, as a quality assurance manager, I manage the overall quality assurance system of the company. Recently, I have been very interested in the regulation of cell culture media. The market for cell culture media is rapidly growing as it is widely used in various research and industrial fields, but the regulations are not yet clearly established. Regulation is crucial for ensuring product quality and safety. Therefore, I am contemplating how to build a system that can meet relevant regulatory requirements and follow international regulatory standards.
Experience at ACK:
You've been with ACK for about 4 months now. What have been some of your key experiences and observations during this time?
I joined ACK in September 2014 and worked with the company for about 5 years before leaving temporarily. It has been 4 months since I rejoined. When I returned to ACK, everyone welcomed me and actively cooperated, allowing me to quickly grasp the company's quality processes. Open communication and collaboration with the team were particularly impressive, and I was pleased to think that we could solve various problems we might face together.
Leadership:
As a leader in the biopharmaceutical industry, what unique perspectives or challenges have you encountered? How do you navigate and overcome these challenges?
The biggest challenge in quality assurance for cell culture media is the lack of clear regulatory standards. This makes it a significant challenge to maintain product consistency and resolve issues when they arise. To respond steadfastly in such situations, a systematic and logical approach based on GMP is required. At this time, cooperation and active communication with team members are crucial. When faced with difficult problems, I try to gather team members' opinions, analyze the issues together, and derive the best solutions. My experience as an initial member when ACK was first established has been a great asset to me. At that time, we all became one team with a same goal, creating and solving all processes together from start to finish. This experience continues to be a driving force in my work and constantly reminds me of the importance of teamwork, especially in challenging situations.
Quality Assurance Challenges:
What do you see as the main challenges in quality assurance for ACK? How do you plan to address these challenges?
Consistency and safety are the most important factors in QA work. All products must meet the same quality standards and be safe for customers to use. Therefore, I believe it is essential to continue building expertise. I particularly want to innovate quality processes by adopting the latest
technologies and further enhance product safety and consistency. Additionally, for cell culture media that are not yet regulated, I plan to define ACK's high quality standards and provide safe and reliable products.
technologies and further enhance product safety and consistency. Additionally, for cell culture media that are not yet regulated, I plan to define ACK's high quality standards and provide safe and reliable products.
QA Processes and Standards:
How do you plan to enhance the existing QA processes and standards at ACK? Are there any new methodologies or practices you would like to introduce?
Based on quality processes that comply with existing GMP and ASQUA, I plan to maintain higher quality while increasing efficiency and strengthening team collaboration and communication. In particular, we plan to hold regular feedback sessions to allow members to freely present their opinions and share process improvement ideas. Through these improvement plans, we can enhance the efficiency of the QA process and strengthen communication and cooperation between teams and departments, thus providing higher quality products. What I consider important is that all decisions should not depend on one leader's thoughts and conclusions, but rather, our thoughts and discussions should be formed. When problems are solved through cooperation and communication with team members, I believe we can grow into a stronger team. While strict standards must be adhered for quality maintenance and customer satisfaction, I also think it is important to respect and reflect diverse opinions and ideas within the group. This can lead to better solutions and enhance team cohesion and efficiency.
Work-Life Balance:
How do you maintain a work-life balance, especially in a demanding role like QA Group Leader? What hobbies or activities do you enjoy in your free time?
After work, I try not to think about work as much as possible. Instead, I aim to maximize efficiency by focusing entirely and not wasting time during working hours. I love traveling, so I always go on trips during my leisure time. In this way, I can feel refreshed and energized when I return. Additionally, when I think from a distance, I realize that the issues and concerns I couldn't resolve at the time are not significant problems when viewed from afar. If I am too confined, my thoughts and mindset also become trapped, so I try to break fixed ideas as much as possible.
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