Job Description
Responsibilities ● Responsible for the whole-process management of production materials, consumables, semi-finished products and finished products in strict accordance with GMP requirements ● Mastery of the principles of DP equipment, familiarity with the production process, you may be able to operate equipment independently and perform basic maintenance of related equipment ● In accordance with GMP requirements, draft and revise related operating procedures, batch production records and related files ● Strictly adhere to change control and deviation investigation process, organize the drafts and implementation of changes, conduct deviation investigations, and establish corrective and preventive actions ● Analyze and solve problems arising in the manufacturing process independently and understand how to contribute to solving problems and optimizing the process through literature review ● Continuously optimize production processes and workflows to ensure production quality and improve production efficiency ● Familiar with project production and transfer processes, capable of conducting gap analysis and project transfer ● As a project lead, communicate internally and externally with other departments and clients to ensure the effective implementation of the project and solve the problems arising in the project ● Participate in designing and recommending new plants ● Participate in audits related to DP manufacturing ● Adherence to company compliance requirements Requirements ● Bachelor’s Degree with a major in any of the relevant disciplines: Pharmaceutical Manufacturing, Pharmaceutical Engineering, Pharmacy, Bioengineering, Biotechnology, Chemical Engineering, Microbiology, etc. ● Knowledge of GMP is preferred, and expertise in aseptic production is an advantage. ● Solid foundational knowledge in pharmacy and biotechnology, with proficiency in Microsoft Office. ● Good English language skills, literature review skills, and a proactive approach to problem-solving in the
