DP Manufacturing Div.
Fill&Finish Team
Asst.Manger Soo Young Jang
Please tell us about your job at Celltrion.
I am tasked with foreign body inspection and the head gas analyzer (HGA) process. My job is to inspect the finished products for defects. Our team examines finished products with the naked eye (foreign body inspection) and use HGAs to measure negative pressure in vials and identify abnormal vials. My role in the process is to prepare and manage inspection documents in terms of deviations, change management, and SOP. I also analyze the latest GMP trends and respond to due diligence by organizations and vendors.
What are the competencies and qualities required of your position?
Our team detects non-conforming types and inspects foreign bodies, and feeds the findings back to the previous processes. These tasks require insight to detect signs of an anomaly, and good communication skills to work with various other teams. We look for foreign bodies and when we find any, we analyze and test the products to determine how they were introduced. To carry out this task, you need the ability to analyze and resolve the issue from multiple angles.
What was your most memorable episode at work?
Celltrion reinforced its foreign body inspection process during its preparation for the FDA’s GMP inspection last year. It was not easy to prepare a large number of documents and improve related processes. However, all team members worked together day and night and successfully completed the inspection and contributed to passing the inspection. The inspection offered me an opportunity to achieve personal growth by working with consulting firms and experiencing the level of global GMP management first-hand.
Do you have any specific goals or visions? If so, what are they?
Currently, I am keenly interested in adopting automatic foreign body inspection equipment and expanding production capacity. I took part in the training course organized by the PDA this May, where I communicated with foreign body inspection employees at other global pharmaceutical companies and reached the proud conclusion that Celltrion is on par with its global competitors in terms of production and quality control. I believe that, through our efforts, Celltrion can improve the competitiveness of its production process.
Do you have anything to say to people looking for employment at Celltrion?
If you value the growth potential of your company and yourself, I highly recommend working here. Celltrion is a biosimilar leader which acquired the first FDA approval in Korea for finished biopharmaceutical products and continues to increase its production capacity at plants in Korea and through CMOs outside of Korea. You can access the know-how and technologies approved by European and American regulators, and gain experience in global production and quality control by participating in process reviews at overseas CMO sites. If you want to be on a fast track for becoming a global talent, apply for a position at our Finished Product Team.
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