The Active Pharmaceutical Ingredient Quality Assurance Team reviews the good manufacturing practice (GMP) documents regarding the reception and release of active pharmaceutical ingredients (APIs), the manufacturing of pharmaceutical products, and the overall quality control (QC) tests. Through these efforts, we ensure that the quality of the finished products conforms to the requirements of regulators in different countries and Celltrion’s standards.
What are the competencies and qualities required of your position?
QA tasks require expertise on pharmaceutical manufacturing processes and clinical test results. In particular, Celltrion uses animal cells for its culture and manufacturing processes.
What was your most memorable episode at work?
The most memorable moment would be when we had our first product, Remsima, approved by an international regulator. I joined the company when Plant 1 was still under construction, and I still remember how we prepared QC documents and processes to persuade the regulator, thereby contributing to bringing out our first biosimilar into the world.
Do you have any specific goals or visions? If so, what are they?
I plan to improve our QC system so as to improve the quality and safety of Celltrion’s biosimilar products. I want to see patients across the world use our safe, high-quality products by implementing thorough QC practices and satisfying national regulators’ regulations and GMP standards.
Do you have anything to say to people looking for employment at Celltrion?
Our team organically collaborates with other departments to fulfill our tasks. That is why we look for people capable of working with, and being considerate of, their co-workers.
Celltrion has world-leading QC capabilities and processes. Gaining QC experience at Celltrion is sure to pave your way to becoming a pharmaceutical quality expert.